P-10, r. 12 - Regulation respecting the terms and conditions for the sale of medications

Full text
SCHEDULE III
(s. 1, 1st par., subpar. 3)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL SUPERVISION


Substance Specification



ACETAMINOPHEN Except dosage forms for oral use in packaging
units containing less than 25 dosage units of
325 mg or less and sold in single packages
containing only one packaging unit

ACETYLSALICYLIC ACID Dosage forms for oral use by adults, except
AND ITS SALTS those in packaging units containing less than
51 dosage units of 325 mg or less and sold in
single packages containing only one packaging
unit

ALOE VERA LATEX, ITS Systemic dosage forms containing 300 mg or
EXTRACTS AND DERIVATIVES, more per dosage unit
EXCEPT ALLOIN

ALUMINUM OXIDE

AMYLOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

ANETHOLTRITHIONE

ANTAZOLINE AND ITS SALTS

ANTIPYRINE Dosage forms for otic use

ATTAPULGITE, ACTIVATED Dosage forms for systemic use recommended for
treating diarrhea

BACITRACINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES

BENZOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes

BENZONATATE

BENZOYL PEROXIDE Dosage forms in concentrations of 5% or less

BERBERIS VULGARIS

BISACODYL AND ITS SALTS

BISMUTH SUBSALICYLATE

BROMPHENIRAMINE AND ITS SALTS

BUPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

BUTENAFINE Dosage forms for vaginal use

CALCIUM POLYCARBOPHIL

CAPSAICIN Dosage forms in concentrations less than 0.075%

CARBINOXAMINE AND ITS SALTS

CASANTHRANOL

CASCARA SAGRADA, ITS Dosage forms containing 325 mg or more per
EXTRACTS AND DERIVATIVES dosage unit

CERAPON

CETIRIZINE AND ITS SALTS Dosage forms in concentrations of 10 mg
(equivalent to 8.5 mg) or less of cetirizine
base per dosage unit

CHARCOAL, ACTIVATED Dosage forms for use in poisoning

CHLOPHEDIANOL AND ITS SALTS

CHLOROPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

CHLORPHENESIN Dosage forms for topical use on the skin

CHLORPHENIRAMINE AND ITS SALTS

CHLORZOXAZONE AND ITS SALTS

CHOLINE SALICYLATE Dosage forms for topical use

CIMETIDINE AND ITS SALTS Dosage forms for oral use containing 100 mg or
less per dosage unit

CLEMASTINE AND ITS SALTS

CLOTRIMAZOLE AND ITS SALTS Dosage forms for vaginal use

COAL TAR Except shampoos or topical preparations in
concentrations of 10% or less

DANTHRON

DEHYDROCHOLIC ACID AND ITS SALTS

DESOXYCHOLIC ACID AND ITS SALTS

DEXBROMPHENIRAMINE AND ITS SALTS

DEXCHLORPHENIRAMINE AND ITS SALTS

DEXTROMETHORPHAN AND ITS SALTS Dosage forms in packaging units containing
850 mg or less and sold in single packages
containing only one packaging unit

DICLOFENAC DIETHYLAMINE Dosage forms for topical use on the skin in
concentrations of 1.16% or less

DIMETHOTHIAZINE

DIPHENHYDRAMINE AND ITS SALTS Except dosage forms for parenteral use

DIPHENYLPYRALINE

DOCUSATE AND ITS SALTS

DOXYLAMINE AND ITS SALTS Except dosage forms sold or recommended for
nausea and vomiting during pregnancy

DYCLONINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

ELECTROLYTES Solution for hydration

Dosage forms for colon cleansing and irrigation

FAMOTIDINE AND ITS SALTS Dosage forms for oral use containing 10 mg or
less per dosage unit

Dosage forms for oral use containing more than
10 mg and not more than 20 mg per dosage unit,
in package units containing less than 51
dosage units

FEXOFENADINE AND ITS SALTS

FLUORIDE AND ITS SALTS Liquid dosage forms

Solid dosage forms for oral use containing 1 mg
or less of elemental fluoride per dosage unit

FRACTAR

GLYCEROARGENTINATE

GLYCOL SALICYLATE

GRAMICIDIN AND ITS SALTS Dosage forms for topical use on the skin

HALOPROGIN

HEPARIN AND ITS SALTS Dosage forms for topical use

HYDROCORTISONE Dosage forms for topical use in concentrations
of 1% or less in packaging units containing
30 g or less

HYDROCORTISONE ACETATE Dosage forms for topical use in concentrations
of 1% or less in packaging units containing
30 g or less

IBUPROFEN AND ITS SALTS Dosage forms containing 200 mg or less per
dosage unit

IODINE, ITS SALTS AND Dosage forms for topical use and dosage forms
DERIVATIVES for oral use with recommended daily dosage
between 0.16 mg and 1 mg

IRON, ITS SALTS AND Dosage forms containing more than 15 mg and
DERIVATIVES less than 30 mg of elemental iron per dosage
unit and drops for children

LACTIC ACID Dosage forms in concentrations greater than 10%

LACTULOSE

LIDOCAINE AND ITS SALTS Dosage forms for topical use on the skin in
concentrations greater than 1%

LOPERAMIDE Solid dosage forms for oral use

LORATADINE, ITS SALTS,
DERIVATIVES AND PREPARATIONS

MAGNESIUM CITRATE Dosage forms for cathartic use

MAGNESIUM SALICYLATE Except oral dosage forms also containing
choline salicylate

MEPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

MEPYRAMINE

METHOCARBAMOL Except dosage forms for parenteral use

METHYL SALICYLATE Except liquid dosage forms in concentrations
greater than 30%

MICONAZOLE AND ITS SALTS Dosage forms for vaginal use

MINERAL TAR Except shampoos with concentrations of 5% or
less

MINOXIDIL Dosage forms for topical use in concentrations
of 5% or less

NAFTIFINE AND ITS SALTS Dosage forms for topical use on the skin

NAPHAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use

NARCOTINE (NOSCAPINE) AND
ITS SALTS

NIACINAMIDE Dosage forms for topical use

NICOTINE AND ITS SALTS Dosage forms sold as chewing gums, inhalers,
lozenges or transdermal nicotine replacement
patches

NIZATIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit

NOSCAPINE (NARCOTINE) AND
ITS SALTS

NYSTATIN, ITS SALTS AND Dosage forms for topical use on the skin
DERIVATIVES

ORPHENADRINE CITRATE

OXETHAZAINE AND ITS SALTS

OXYBUPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

OXYMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use

PANCREATIC ENZYMES Except dosage forms recommended for cystic
fibrosis treatment

PANCREATIN

PHENIRAMINE AND ITS SALTS

PHENYLEPHRINE AND ITS SALTS Dosage forms for ophthalmic use in
concentrations of 2.5% or less

PHENYLPROPANOLAMINE AND ITS SALTS

PHENYLTOLOXAMINE AND ITS SALTS

PINE TAR Except shampoos in concentrations of 5% or less

POLYMYXINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES

POVIDONE-IODINE Dosage forms for topical use except in
concentrations of 5% or less

PRAMOXINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PRILOCAINE AND ITS SALTS Dosage forms for topical use on the skin

PROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PROMETHAZINE AND ITS SALTS Dosage forms for topical use on the skin

PROPARACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PSEUDOEPHEDRINE AND ITS SALTS Dosage forms in packaging units containing
1,200 mg or less, sold in single packages
containing only one packaging unit and
containing another medicinal ingredient

PYRILAMINE AND ITS SALTS

RANITIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit

Dosage forms for oral use containing more than
75 mg and not more than 150 mg per dosage
unit, in package units containing less than 51
dosage units

SENNA, ITS EXTRACTS AND Dosage forms containing 8.6 mg or more of senna
DERIVATIVES lycoside per dosage unit

SODIUM BIPHOSPHATE Dosage forms for cathartic use

SODIUM CITRATE Dosage forms use as urinary alkalizer

SODIUM CROMOGLICATE Dosage forms for nasal use in concentrations
of 2% or less

SODIUM LAURYL SULFOACETATE Dosage forms for cathartic use

SODIUM PHOSPHATE Dosage forms for cathartic use

SODIUM SALICYLATE

SODIUM TARTRATE Dosage forms for cathartic use

TETRACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

TETRAHYDROZOLINE Dosage forms for nasal or ophthalmic use

TIOCONAZOLE Dosage forms for vaginal use

TRIETHANOLAMINE OLEATE

TRIETHANOLAMINE SALICYLATE Dosage forms for topical use in concentrations
greater than 20%

TRIPELENNAMINE AND ITS SALTS

TRIPROLIDINE

TYROTHRICINE

XYLOMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
O.C. 712-98, Sch. III; O.C. 54-2001, s. 3; O.C. 698-2001, s. 2; O.C. 840-2003, s. 1; O.C. 998-2005, s. 2; O.C. 1024-2009, ss. 1, 2 and 3; O.C. 1069-2015, s. 2; O.C. 688-2016, s. 1; 1004-2021O.C. 1004-2021, s. 1.
SCHEDULE III
(s. 1, 1st par., subpar. 3)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL SUPERVISION


Substance Specification



ACETAMINOPHEN Except dosage forms for oral use in packaging
units containing less than 25 dosage units of
325 mg or less and sold in single packages
containing only one packaging unit

ACETYLSALICYLIC ACID Dosage forms for oral use by adults, except
AND ITS SALTS those in packaging units containing less than
51 dosage units of 325 mg or less and sold in
single packages containing only one packaging
unit

ALOE VERA LATEX, ITS Systemic dosage forms containing 300 mg or
EXTRACTS AND DERIVATIVES, more per dosage unit
EXCEPT ALLOIN

ALUMINUM OXIDE

AMYLOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

ANETHOLTRITHIONE

ANTAZOLINE AND ITS SALTS

ANTIPYRINE Dosage forms for otic use

ATTAPULGITE, ACTIVATED Dosage forms for systemic use recommended for
treating diarrhea

BACITRACINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES

BENZOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes

BENZONATATE

BENZOYL PEROXIDE Dosage forms in concentrations of 5% or less

BERBERIS VULGARIS

BISACODYL AND ITS SALTS

BISMUTH SUBSALICYLATE

BROMPHENIRAMINE AND ITS SALTS

BUPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

BUTENAFINE Dosage forms for vaginal use

CALCIUM POLYCARBOPHIL

CAPSAICIN Dosage forms in concentrations less than 0.075%

CARBINOXAMINE AND ITS SALTS

CASANTHRANOL

CASCARA SAGRADA, ITS Dosage forms containing 325 mg or more per
EXTRACTS AND DERIVATIVES dosage unit

CERAPON

CETIRIZINE AND ITS SALTS Dosage forms in concentrations of 10 mg
(equivalent to 8.5 mg) or less of cetirizine
base per dosage unit

CHARCOAL, ACTIVATED Dosage forms for use in poisoning

CHLOPHEDIANOL AND ITS SALTS

CHLOROPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

CHLORPHENESIN Dosage forms for topical use on the skin

CHLORPHENIRAMINE AND ITS SALTS

CHLORZOXAZONE AND ITS SALTS

CHOLINE SALICYLATE Dosage forms for topical use

CIMETIDINE AND ITS SALTS Dosage forms for oral use containing 100 mg or
less per dosage unit

CLEMASTINE AND ITS SALTS

CLOTRIMAZOLE AND ITS SALTS Dosage forms for vaginal use

COAL TAR Except shampoos or topical preparations in
concentrations of 10% or less

DANTHRON

DEHYDROCHOLIC ACID AND ITS SALTS

DESOXYCHOLIC ACID AND ITS SALTS

DEXBROMPHENIRAMINE AND ITS SALTS

DEXCHLORPHENIRAMINE AND ITS SALTS

DEXTROMETHORPHAN AND ITS SALTS Dosage forms in packaging units containing
850 mg or less and sold in single packages
containing only one packaging unit

DIMETHOTHIAZINE

DIPHENHYDRAMINE AND ITS SALTS Except dosage forms for parenteral use

DIPHENYLPYRALINE

DOCUSATE AND ITS SALTS

DOXYLAMINE AND ITS SALTS Except dosage forms sold or recommended for
nausea and vomiting during pregnancy

DYCLONINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

ELECTROLYTES Solution for hydration

Dosage forms for colon cleansing and irrigation

FAMOTIDINE AND ITS SALTS Dosage forms for oral use containing 10 mg or
less per dosage unit

Dosage forms for oral use containing more than
10 mg and not more than 20 mg per dosage unit,
in package units containing less than 51
dosage units

FEXOFENADINE AND ITS SALTS

FLUORIDE AND ITS SALTS Liquid dosage forms

Solid dosage forms for oral use containing 1 mg
or less of elemental fluoride per dosage unit

FRACTAR

GLYCEROARGENTINATE

GLYCOL SALICYLATE

GRAMICIDIN AND ITS SALTS Dosage forms for topical use on the skin

HALOPROGIN

HEPARIN AND ITS SALTS Dosage forms for topical use

HYDROCORTISONE Dosage forms for topical use in concentrations
of 1% or less in packaging units containing
30 g or less

HYDROCORTISONE ACETATE Dosage forms for topical use in concentrations
of 1% or less in packaging units containing
30 g or less

IBUPROFEN AND ITS SALTS Dosage forms containing 200 mg or less per
dosage unit

IODINE, ITS SALTS AND Dosage forms for topical use and dosage forms
DERIVATIVES for oral use with recommended daily dosage
between 0.16 mg and 1 mg

IRON, ITS SALTS AND Dosage forms containing more than 15 mg and
DERIVATIVES less than 30 mg of elemental iron per dosage
unit and drops for children

LACTIC ACID Dosage forms in concentrations greater than 10%

LACTULOSE

LIDOCAINE AND ITS SALTS Dosage forms for topical use on the skin in
concentrations greater than 1%

LOPERAMIDE Solid dosage forms for oral use

LORATADINE, ITS SALTS,
DERIVATIVES AND PREPARATIONS

MAGNESIUM CITRATE Dosage forms for cathartic use

MAGNESIUM SALICYLATE Except oral dosage forms also containing
choline salicylate

MEPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

MEPYRAMINE

METHOCARBAMOL Except dosage forms for parenteral use

METHYL SALICYLATE Except liquid dosage forms in concentrations
greater than 30%

MICONAZOLE AND ITS SALTS Dosage forms for vaginal use

MINERAL TAR Except shampoos with concentrations of 5% or
less

MINOXIDIL Dosage forms for topical use in concentrations
of 5% or less

NAFTIFINE AND ITS SALTS Dosage forms for topical use on the skin

NAPHAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use

NARCOTINE (NOSCAPINE) AND
ITS SALTS

NIACINAMIDE Dosage forms for topical use

NICOTINE AND ITS SALTS Dosage forms sold as chewing gums, inhalers,
lozenges or transdermal nicotine replacement
patches

NIZATIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit

NOSCAPINE (NARCOTINE) AND
ITS SALTS

NYSTATIN, ITS SALTS AND Dosage forms for topical use on the skin
DERIVATIVES

ORPHENADRINE CITRATE

OXETHAZAINE AND ITS SALTS

OXYBUPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

OXYMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use

PANCREATIC ENZYMES Except dosage forms recommended for cystic
fibrosis treatment

PANCREATIN

PHENIRAMINE AND ITS SALTS

PHENYLEPHRINE AND ITS SALTS Dosage forms for ophthalmic use in
concentrations of 2.5% or less

PHENYLPROPANOLAMINE AND ITS SALTS

PHENYLTOLOXAMINE AND ITS SALTS

PINE TAR Except shampoos in concentrations of 5% or less

POLYMYXINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES

POVIDONE-IODINE Dosage forms for topical use except in
concentrations of 5% or less

PRAMOXINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PRILOCAINE AND ITS SALTS Dosage forms for topical use on the skin

PROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PROMETHAZINE AND ITS SALTS Dosage forms for topical use on the skin

PROPARACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PSEUDOEPHEDRINE AND ITS SALTS Dosage forms in packaging units containing
1,200 mg or less, sold in single packages
containing only one packaging unit and
containing another medicinal ingredient

PYRILAMINE AND ITS SALTS

RANITIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit

Dosage forms for oral use containing more than
75 mg and not more than 150 mg per dosage
unit, in package units containing less than 51
dosage units

SENNA, ITS EXTRACTS AND Dosage forms containing 8.6 mg or more of senna
DERIVATIVES lycoside per dosage unit

SODIUM BIPHOSPHATE Dosage forms for cathartic use

SODIUM CITRATE Dosage forms use as urinary alkalizer

SODIUM CROMOGLICATE Dosage forms for nasal use in concentrations
of 2% or less

SODIUM LAURYL SULFOACETATE Dosage forms for cathartic use

SODIUM PHOSPHATE Dosage forms for cathartic use

SODIUM SALICYLATE

SODIUM TARTRATE Dosage forms for cathartic use

TETRACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

TETRAHYDROZOLINE Dosage forms for nasal or ophthalmic use

TIOCONAZOLE Dosage forms for vaginal use

TRIETHANOLAMINE OLEATE

TRIETHANOLAMINE SALICYLATE Dosage forms for topical use in concentrations
greater than 20%

TRIPELENNAMINE AND ITS SALTS

TRIPROLIDINE

TYROTHRICINE

XYLOMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
O.C. 712-98, Sch. III; O.C. 54-2001, s. 3; O.C. 698-2001, s. 2; O.C. 840-2003, s. 1; O.C. 998-2005, s. 2; O.C. 1024-2009, ss. 1, 2 and 3; O.C. 1069-2015, s. 2; O.C. 688-2016, s. 1.
SCHEDULE III
(s. 1, 1st par., subpar. 3)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL SUPERVISION


Substance Specification



ACETAMINOPHEN Except dosage forms for oral use in packaging
units containing less than 25 dosage units of
325 mg or less and sold in single packages
containing only one packaging unit

ACETYLSALICYLIC ACID Dosage forms for oral use by adults, except
AND ITS SALTS those in packaging units containing less than
51 dosage units of 325 mg or less and sold in
single packages containing only one packaging
unit

ALOE VERA LATEX, ITS Systemic dosage forms containing 300 mg or
EXTRACTS AND DERIVATIVES, more per dosage unit
EXCEPT ALLOIN

ALUMINUM OXIDE

AMYLOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

ANETHOLTRITHIONE

ANTAZOLINE AND ITS SALTS

ANTIPYRINE Dosage forms for otic use

ATTAPULGITE, ACTIVATED Dosage forms for systemic use recommended for
treating diarrhea

BACITRACINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES

BENZOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes

BENZONATATE

BENZOYL PEROXIDE Dosage forms in concentrations of 5% or less

BERBERIS VULGARIS

BISACODYL AND ITS SALTS

BISMUTH SUBSALICYLATE

BROMPHENIRAMINE AND ITS SALTS

BUPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

BUTENAFINE Dosage forms for vaginal use

CALCIUM POLYCARBOPHIL

CAPSAICIN Dosage forms in concentrations less than 0.075%

CARBINOXAMINE AND ITS SALTS

CASANTHRANOL

CASCARA SAGRADA, ITS Dosage forms containing 325 mg or more per
EXTRACTS AND DERIVATIVES dosage unit

CERAPON

CETIRIZINE AND ITS SALTS Dosage forms in concentrations of 10 mg
(equivalent to 8.5 mg) or less of cetirizine
base per dosage unit

CHARCOAL, ACTIVATED Dosage forms for use in poisoning

CHLOPHEDIANOL AND ITS SALTS

CHLOROPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

CHLORPHENESIN Dosage forms for topical use on the skin

CHLORPHENIRAMINE AND ITS SALTS

CHLORZOXAZONE AND ITS SALTS

CHOLINE SALICYLATE Dosage forms for topical use

CIMETIDINE AND ITS SALTS Dosage forms for oral use containing 100 mg or
less per dosage unit

CLEMASTINE AND ITS SALTS

CLOTRIMAZOLE AND ITS SALTS Dosage forms for vaginal use

COAL TAR Except shampoos or topical preparations in
concentrations of 10% or less

DANTHRON

DEHYDROCHOLIC ACID AND ITS SALTS

DESOXYCHOLIC ACID AND ITS SALTS

DEXBROMPHENIRAMINE AND ITS SALTS

DEXCHLORPHENIRAMINE AND ITS SALTS

DEXTROMETHORPHAN AND ITS SALTS Dosage forms in packaging units containing
850 mg or less and sold in single packages
containing only one packaging unit

DIMETHOTHIAZINE

DIPHENHYDRAMINE AND ITS SALTS Except dosage forms for parenteral use

DIPHENYLPYRALINE

DOCUSATE AND ITS SALTS

DOXYLAMINE AND ITS SALTS Except dosage forms sold or recommended for
nausea and vomiting during pregnancy

DYCLONINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

ELECTROLYTES Solution for hydration

Dosage forms for colon cleansing and irrigation

FAMOTIDINE AND ITS SALTS Dosage forms for oral use containing 10 mg or
less per dosage unit

Dosage forms for oral use containing more than
10 mg and not more than 20 mg per dosage unit,
in package units containing less than 51
dosage units

FEXOFENADINE AND ITS SALTS

FLUORIDE AND ITS SALTS Liquid dosage forms

Solid dosage forms for oral use containing 1 mg
or less of elemental fluoride per dosage unit

FRACTAR

GLYCEROARGENTINATE

GLYCOL SALICYLATE

GRAMICIDIN AND ITS SALTS Dosage forms for topical use on the skin

HALOPROGIN

HEPARIN AND ITS SALTS Dosage forms for topical use

HYDROCORTISONE Dosage forms for topical use in concentrations
of 0.5%

HYDROCORTISONE ACETATE Dosage forms for topical use in concentrations
of 0.5%

IBUPROFEN AND ITS SALTS Dosage forms containing 200 mg or less per
dosage unit

IODINE, ITS SALTS AND Dosage forms for topical use and dosage forms
DERIVATIVES for oral use with recommended daily dosage
between 0.16 mg and 1 mg

IRON, ITS SALTS AND Dosage forms containing more than 15 mg and
DERIVATIVES less than 30 mg of elemental iron per dosage
unit and drops for children

LACTIC ACID Dosage forms in concentrations greater than 10%

LACTULOSE

LIDOCAINE AND ITS SALTS Dosage forms for topical use on the skin in
concentrations greater than 1%

LOPERAMIDE Solid dosage forms for oral use

LORATADINE, ITS SALTS,
DERIVATIVES AND PREPARATIONS

MAGNESIUM CITRATE Dosage forms for cathartic use

MAGNESIUM SALICYLATE Except oral dosage forms also containing
choline salicylate

MEPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

MEPYRAMINE

METHOCARBAMOL Except dosage forms for parenteral use

METHYL SALICYLATE Except liquid dosage forms in concentrations
greater than 30%

MICONAZOLE AND ITS SALTS Dosage forms for vaginal use

MINERAL TAR Except shampoos with concentrations of 5% or
less

MINOXIDIL Dosage forms for topical use in concentrations
of 2% or less

NAFTIFINE AND ITS SALTS Dosage forms for topical use on the skin

NAPHAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use

NARCOTINE (NOSCAPINE) AND
ITS SALTS

NIACINAMIDE Dosage forms for topical use

NICOTINE AND ITS SALTS Dosage forms sold as chewing gums, inhalers,
lozenges or transdermal nicotine replacement
patches

NIZATIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit

NOSCAPINE (NARCOTINE) AND
ITS SALTS

NYSTATIN, ITS SALTS AND Dosage forms for topical use on the skin
DERIVATIVES

ORPHENADRINE CITRATE

OXETHAZAINE AND ITS SALTS

OXYBUPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

OXYMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use

PANCREATIC ENZYMES Except dosage forms recommended for cystic
fibrosis treatment

PANCREATIN

PHENIRAMINE AND ITS SALTS

PHENYLEPHRINE AND ITS SALTS Dosage forms for ophthalmic use in
concentrations of 2.5% or less

PHENYLPROPANOLAMINE AND ITS SALTS

PHENYLTOLOXAMINE AND ITS SALTS

PINE TAR Except shampoos in concentrations of 5% or less

POLYMYXINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES

POVIDONE-IODINE Dosage forms for topical use except in
concentrations of 5% or less

PRAMOXINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PRILOCAINE AND ITS SALTS Dosage forms for topical use on the skin

PROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PROMETHAZINE AND ITS SALTS Dosage forms for topical use on the skin

PROPARACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PSEUDOEPHEDRINE AND ITS SALTS Dosage forms in packaging units containing
1,200 mg or less, sold in single packages
containing only one packaging unit and
containing another medicinal ingredient

PYRILAMINE AND ITS SALTS

RANITIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit

Dosage forms for oral use containing more than
75 mg and not more than 150 mg per dosage
unit, in package units containing less than 51
dosage units

SENNA, ITS EXTRACTS AND Dosage forms containing 8.6 mg or more of senna
DERIVATIVES lycoside per dosage unit

SODIUM BIPHOSPHATE Dosage forms for cathartic use

SODIUM CITRATE Dosage forms use as urinary alkalizer

SODIUM CROMOGLICATE Dosage forms for nasal use in concentrations
of 2% or less

SODIUM LAURYL SULFOACETATE Dosage forms for cathartic use

SODIUM PHOSPHATE Dosage forms for cathartic use

SODIUM SALICYLATE

SODIUM TARTRATE Dosage forms for cathartic use

TETRACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

TETRAHYDROZOLINE Dosage forms for nasal or ophthalmic use

TIOCONAZOLE Dosage forms for vaginal use

TRIETHANOLAMINE OLEATE

TRIETHANOLAMINE SALICYLATE Dosage forms for topical use in concentrations
greater than 20%

TRIPELENNAMINE AND ITS SALTS

TRIPROLIDINE

TYROTHRICINE

XYLOMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
O.C. 712-98, Sch. III; O.C. 54-2001, s. 3; O.C. 698-2001, s. 2; O.C. 840-2003, s. 1; O.C. 998-2005, s. 2; O.C. 1024-2009, ss. 1, 2 and 3; O.C. 1069-2015, s. 2.
SCHEDULE III
(s. 1, 1st par., subpar. 3)
MEDICATIONS FOR HUMAN USE SOLD UNDER PHARMACEUTICAL SUPERVISION


Substance Specification



ACETAMINOPHEN Except dosage forms for oral use in packaging
units containing less than 25 dosage units of
325 mg or less and sold in single packages
containing only one packaging unit

ACETYLSALICYLIC ACID Dosage forms for oral use by adults, except
AND ITS SALTS those in packaging units containing less than
51 dosage units of 325 mg or less and sold in
single packages containing only one packaging
unit

ALOE VERA LATEX, ITS Systemic dosage forms containing 300 mg or
EXTRACTS AND DERIVATIVES, more per dosage unit
EXCEPT ALLOIN

ALUMINUM OXIDE

AMYLOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

ANETHOLTRITHIONE

ANTAZOLINE AND ITS SALTS

ANTIPYRINE Dosage forms for otic use

ATTAPULGITE, ACTIVATED Dosage forms for systemic use recommended for
treating diarrhea

BACITRACINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES

BENZOCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes

BENZONATATE

BENZOYL PEROXIDE Dosage forms in concentrations of 5% or less

BERBERIS VULGARIS

BISACODYL AND ITS SALTS

BISMUTH SUBSALICYLATE

BROMPHENIRAMINE AND ITS SALTS

BUPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

BUTENAFINE Dosage forms for vaginal use

CALCIUM POLYCARBOPHIL

CAPSAICIN Dosage forms in concentrations less than 0.075%

CARBINOXAMINE AND ITS SALTS

CASANTHRANOL

CASCARA SAGRADA, ITS Dosage forms containing 325 mg or more per
EXTRACTS AND DERIVATIVES dosage unit

CERAPON

CETIRIZINE AND ITS SALTS Dosage forms in concentrations of 10 mg
(equivalent to 8.5 mg) or less of cetirizine
base per dosage unit

CHARCOAL, ACTIVATED Dosage forms for use in poisoning

CHLOPHEDIANOL AND ITS SALTS

CHLOROPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

CHLORPHENESIN Dosage forms for topical use on the skin

CHLORPHENIRAMINE AND ITS SALTS

CHLORZOXAZONE AND ITS SALTS

CHOLINE SALICYLATE Dosage forms for topical use

CIMETIDINE AND ITS SALTS Dosage forms for oral use containing 100 mg or
less per dosage unit

CLEMASTINE AND ITS SALTS

CLOTRIMAZOLE AND ITS SALTS Dosage forms for vaginal use

COAL TAR Except shampoos or topical preparations in
concentrations of 10% or less

DANTHRON

DEHYDROCHOLIC ACID AND ITS SALTS

DESOXYCHOLIC ACID AND ITS SALTS

DEXBROMPHENIRAMINE AND ITS SALTS

DEXCHLORPHENIRAMINE AND ITS SALTS

DEXTROMETHORPHAN AND ITS SALTS

DIMETHOTHIAZINE

DIPHENHYDRAMINE AND ITS SALTS Except dosage forms for parenteral use

DIPHENYLPYRALINE

DOCUSATE AND ITS SALTS

DOXYLAMINE AND ITS SALTS Except dosage forms sold or recommended for
nausea and vomiting during pregnancy

DYCLONINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

ELECTROLYTES Solution for hydration

Dosage forms for colon cleansing and irrigation

FAMOTIDINE AND ITS SALTS Dosage forms for oral use containing 10 mg or
less per dosage unit

Dosage forms for oral use containing more than
10 mg and not more than 20 mg per dosage unit,
in package units containing less than 51
dosage units

FEXOFENADINE AND ITS SALTS

FLUORIDE AND ITS SALTS Liquid dosage forms

Solid dosage forms for oral use containing 1 mg
or less of elemental fluoride per dosage unit

FRACTAR

GLYCEROARGENTINATE

GLYCOL SALICYLATE

GRAMICIDIN AND ITS SALTS Dosage forms for topical use on the skin

HALOPROGIN

HEPARIN AND ITS SALTS Dosage forms for topical use

HYDROCORTISONE Dosage forms for topical use in concentrations
of 0.5%

HYDROCORTISONE ACETATE Dosage forms for topical use in concentrations
of 0.5%

IBUPROFEN AND ITS SALTS Dosage forms containing 200 mg or less per
dosage unit

IODINE, ITS SALTS AND Dosage forms for topical use and dosage forms
DERIVATIVES for oral use with recommended daily dosage
between 0.16 mg and 1 mg

IRON, ITS SALTS AND Dosage forms containing more than 15 mg and
DERIVATIVES less than 30 mg of elemental iron per dosage
unit and drops for children

LACTIC ACID Dosage forms in concentrations greater than 10%

LACTULOSE

LIDOCAINE AND ITS SALTS Dosage forms for topical use on the skin in
concentrations greater than 1%

LOPERAMIDE Solid dosage forms for oral use

LORATADINE, ITS SALTS,
DERIVATIVES AND PREPARATIONS

MAGNESIUM CITRATE Dosage forms for cathartic use

MAGNESIUM SALICYLATE Except oral dosage forms also containing
choline salicylate

MEPIVACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

MEPYRAMINE

METHOCARBAMOL Except dosage forms for parenteral use

METHYL SALICYLATE Except liquid dosage forms in concentrations
greater than 30%

MICONAZOLE AND ITS SALTS Dosage forms for vaginal use

MINERAL TAR Except shampoos with concentrations of 5% or
less

MINOXIDIL Dosage forms for topical use in concentrations
of 2% or less

NAFTIFINE AND ITS SALTS Dosage forms for topical use on the skin

NAPHAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use

NARCOTINE (NOSCAPINE) AND
ITS SALTS

NIACINAMIDE Dosage forms for topical use

NICOTINE AND ITS SALTS Dosage forms sold as chewing gums, inhalers,
lozenges or transdermal nicotine replacement
patches

NIZATIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit

NOSCAPINE (NARCOTINE) AND
ITS SALTS

NYSTATIN, ITS SALTS AND Dosage forms for topical use on the skin
DERIVATIVES

ORPHENADRINE CITRATE

OXETHAZAINE AND ITS SALTS

OXYBUPROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

OXYMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use

PANCREATIC ENZYMES Except dosage forms recommended for cystic
fibrosis treatment

PANCREATIN

PHENIRAMINE AND ITS SALTS

PHENYLEPHRINE AND ITS SALTS Dosage forms for ophthalmic use in
concentrations of 2.5% or less

PHENYLPROPANOLAMINE AND ITS SALTS

PHENYLTOLOXAMINE AND ITS SALTS

PINE TAR Except shampoos in concentrations of 5% or less

POLYMYXINS, THEIR SALTS Dosage forms for topical use on the skin
AND DERIVATIVES

POVIDONE-IODINE Dosage forms for topical use except in
concentrations of 5% or less

PRAMOXINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PRILOCAINE AND ITS SALTS Dosage forms for topical use on the skin

PROCAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PROMETHAZINE AND ITS SALTS Dosage forms for topical use on the skin

PROPARACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

PSEUDOEPHEDRINE AND ITS SALTS Dosage forms in concentrations of more than
30 mg or containing more than 25 dosage units
sold in single packages containing only one
packaging unit

Dose forms for children

PYRILAMINE AND ITS SALTS

RANITIDINE AND ITS SALTS Dosage forms for oral use containing 75 mg or
less per dosage unit

Dosage forms for oral use containing more than
75 mg and not more than 150 mg per dosage
unit, in package units containing less than 51
dosage units

SENNA, ITS EXTRACTS AND Dosage forms containing 8.6 mg or more of senna
DERIVATIVES lycoside per dosage unit

SODIUM BIPHOSPHATE Dosage forms for cathartic use

SODIUM CITRATE Dosage forms use as urinary alkalizer

SODIUM CROMOGLICATE Dosage forms for nasal use in concentrations
of 2% or less

SODIUM LAURYL SULFOACETATE Dosage forms for cathartic use

SODIUM PHOSPHATE Dosage forms for cathartic use

SODIUM SALICYLATE

SODIUM TARTRATE Dosage forms for cathartic use

TETRACAINE AND ITS SALTS Dosage forms for topical use on mucous
membranes, except lozenges

TETRAHYDROZOLINE Dosage forms for nasal or ophthalmic use

TIOCONAZOLE Dosage forms for vaginal use

TRIETHANOLAMINE OLEATE

TRIETHANOLAMINE SALICYLATE Dosage forms for topical use in concentrations
greater than 20%

TRIPELENNAMINE AND ITS SALTS

TRIPROLIDINE

TYROTHRICINE

XYLOMETAZOLINE AND ITS SALTS Dosage forms for nasal or ophthalmic use
O.C. 712-98, Sch. III; O.C. 54-2001, s. 3; O.C. 698-2001, s. 2; O.C. 840-2003, s. 1; O.C. 998-2005, s. 2; O.C. 1024-2009, ss. 1, 2 and 3.