A Summary of NHP/DRUG Classification of TPD Category IV Labelling Standards Ingredients

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Note: Rationale for the classification decision will be provided upon request

TPD Category IV Monograph/ Labelling Standard	Medicinal Ingredients	NHP / DRUG
1- Category IV Monographs
Acne Therapy	Benzoyl peroxide	Drug
	Resorcinol	NHP
	Resorcinol monoacetate	NHP
	Salicylic Acid	NHP
	Sulphur	NHP
Antidandruff Products	Coal Tar	Drug
	Pyrithione Zinc	Drug
	Salicylic Acid	NHP
	Selenium Sulfide	NHP
	Sulphur	NHP
Antiperspirants	Aluminum Chloride	NHP
	Aluminum Chlorohydrate	NHP
	Aluminum Chlorohydrex	NHP
	Aluminum Dichlorohydrate	NHP
	Aluminum Sesquichlorohydrate	NHP
	Aluminum Zirconium Octachlorohydrate	NHP
	Aluminum Zirconium Octachlorohydrex Gly	NHP
	Aluminum Zirconium Pentachlorohydrate	NHP
	Aluminum Zirconium Pentachlorohydrex Gly	NHP
	Aluminum Zirconium Tetrachlorohydrate	NHP
	Aluminum Zirconium Tetrachlorohydrex Gly	NHP
	Aluminum Zirconium Trichlorohydrate	NHP
	Aluminum Zirconium Trichlorohydrex Gly	NHP
Antiseptic Skin Cleansers	Benzalkonium Chloride	Drug
	Benzethonium Chloride	Drug
	Chlorhexidine Gluconate	Drug
	Chloroxylenol	Drug
	Ethyl Alcohol	NHP
	Isopropyl Alcohol	NHP
	Methylbenzethonium chloride	Drug
	Povidone Iodine	NHP
	Triclocarban	Drug
	Triclosan	Drug
	Salicylic Acid	NHP
Athlete's Foot Treatments	Calcium undecylenate	NHP
	Chlorphenesin	Drug
	Clioquinol (Iodochlorhydroxyquin)	Drug
	Copper undecylenate	NHP
	Haloprogin	Drug
	Povidone Iodine	NHP
	Tolnaftate	Drug
	Undecylenic Acid	NHP
	Zinc undecylenate	NHP
Contact Lens Disinfectants	All disinfectants are excluded from NHP Regulations by definition. See FDA definition of Drug 2 (c) - disinfectants distinguished from drugs for human use; F&D Regulations C.01.04.1(2)(g) compared to NHP 1.(1) definition of NHP - NHPs are always "for use in humans".
	Alkyltriethanolammonium chloride (Quaternium-16)	Drug
	Benzalkonium chloride (Alkyl dimethyl benzyl ammonium chloride)	Drug
	Chlorhexidine gluconate	Drug
	EDTA	Drug
	Hydrogen Peroxide	Drug for this indication
	Isopropyl Alcohol (Isopropanol)	NHP
	Polyaminopropyl biguanide	Drug
	Polyquaternium-1 (Polyquad)	Drug
	Polyhexanide	Drug
	Tris (2-hydroxyethyl) tallow ammonium chloride	Drug
Dietary Mineral Supplements	Calcium	NHP
	Copper	NHP
	Iodine	NHP
	Magnesium	NHP
	Phosphorus	NHP
Note: all derivatives in Appendix III are acceptable as NHP sources
Dietary Vitamin Supplements	Beta-carotene	NHP ≤ 10 000 IU/day of Vitamin A equivalents
	Biotin	NHP
	Folic acid	NHP ≤ 1 mg/day
	Niacin/Niacinamide	NHP
	Pantothenic Acid	NHP
	Vitamin A	NHP ≤ 10 000 IU/day
	Vitamin B1	NHP
	Vitamin B2	NHP
	Vitamin B6	NHP
	Vitamin B12	NHP
	Vitamin C	NHP
	Vitamin D (Vitamin D2 or Vitamin D3)	NHP ≤ 1 000 IU/day
	Vitamin E	NHP
Note: all derivatives in Appendix IV are acceptable as NHP sources
Fluoride Containing Anti-caries Products	Acidulated Phosphate Fluoride	NHP
	Sodium Fluoride	NHP
	Sodium Monofluorophosphate	NHP
	Stannous Fluoride	NHP
Hard Surface Disinfectants	All disinfectants are excluded from NHP Regulations by definition. See FDA definition of Drug 2 (c) - disinfectants distinguished from drugs for human use; F&D Regulations C.01.04.1(2)(g) compared to NHP 1.(1) definition of NHP - NHPs are always "for use in humans".
	Alkyl ethyl benzyl dimethyl ammonium chloride	Drug
	Aralkonium chloride (Alkyl dimethyl-3, 4-dichlorobenzyl ammonium chloride)	Drug
	Benzalkonium chloride (Alkyl dimethyl benzyl ammonium chloride)	Drug
	Calcium hypochlorite	Drug
	Cetalkonium chloride (Cetyl dimethyl benzyl ammonium chloride)	Drug
	Chloro-ortho-phenylphenol (Chloro-2-phenylphenol)	Drug
	Chlorophenol	Drug
	Clorophene (o-benzyl-p-chlorophenol)	Drug
	Didecyl dimethyl ammonium chloride (Chloride didecyl dimethylammonium)	Drug
	Dioctyl dimethyl ammonium chloride (Chloride dioctyl dimethylammonium)	Drug
	Hexadecyl dimethyl benzyl ammonium chloride (Chloride hexadecyldimethylbenzyl ammonium)	Drug
	Methyl dodecyl benzyl trimethyl ammonium chloride (Chloride methyl dodecyl benzyl trimethyl ammonium)	Drug
	Nonylphenoxy polyethoxyethanol iodine complex (Nonoxynol iodophor A-P-nonylphenyl- omega-hydroxypoly oxyethylene iodine complex)	Drug
	Octa decyl dimethyl benzyl ammonium chloride (Chloride octadecyl dimethylbenzyl ammonium)	Drug
	Octyl decyl dimethyl ammonium chloride (Chloride octyl decyl dimethyl ammonium)	Drug
	Octyl dimethyl ammonium chloride (Chloride octyl dimethyl ammonium)	Drug
	o-phenylphenol (orthoxenol)	Drug
	p-phenylphenol (paraxenol)	Drug
	p-tert-pentylphenol (p-tert-amylphenol)	Drug
	Polyethoxy polypropoxy polyethoxy ethanol iodine complex (Iodine polyethoxy polypropoxy polyethoxy ethanol)	Drug
	Sodium hypochlorite	Drug
Medicated Skin Care Products	Allantoin	NHP
	Almond Oil	NHP
	Calamine	NHP
	Cocoa Butter	NHP
	Colloidal Oatmeal	NHP
	Corn Starch	NHP
	Dimethicone	Drug
	Glycerine	NHP
	Isopropyl Myristate	Drug
	Lactic Acid	NHP
	Lanolin	NHP
	Mineral Oil	Drug
	Olive Oil	NHP
	Urea	NHP
	White Petrolatum	Drug
	Zinc Oxide	NHP
Sunburn Protectants	Avobenzone	Drug
	Cinoxate	Drug
	Diethanolamine- methoxycinnamate	Drug
	Dioxybenzone	Drug
	Ensulizole	Drug
	Enzacamene	Drug
	Ethyl Dihydroxypropyl PABA	Drug
	Glycerol PABA	Drug
	Homosalate	Drug
	Meradimate	Drug
	Octinoxate	Drug
	Octisalate	Drug
	Octocrylene	Drug
	Oxybenzone	Drug
	PABA	NHP
	Padimate-O	Drug
	Sulisobenzone	Drug
	Terephthalylidene dicamphor sulfonic acid	Drug
	Titanium Dioxide	NHP
	Triethanolamine Salicylate	Drug
	Zinc Oxide	NHP
Throat Lozenges	Benzocaine	NHP
	Benzyl Alcohol	NHP
	Cetylpyridinium chloride	Drug
	Dequalinium chloride	Drug
	Domiphen bromide	Drug
	Dyclonine Hydrochloride	Drug
	Gelatin	NHP
	Hexylresorcinol	Drug
	Menthol	NHP
	Pectin	NHP
	Phenol	NHP
	Salicyl Alcohol	NHP
	Slippery Elm Bark powder	NHP
Toilet Bowl Disinfectant Cleaners	All disinfectants are excluded from NHP Regulations by definition. See FDA definition of Drug 2 (c) - disinfectants distinguished from drugs for human use; F&D Regulations C.01.04.1(2)(g) compared to NHP 1.(1) definition of NHP - NHPs are always "for use in humans".
	Alkyl ethyl benzyl dimethyl ammonium chloride	Drug
	Aralkonium chloride (Alkyl dimethyl-3, 4-dichlorobenzyl ammonium chloride)	Drug
	Benzalkonium chloride (Alkyl dimethyl benzyl ammonium chloride)	Drug
	Cetalkonium chloride (Cetyl dimethyl benzyl ammonium chloride)	Drug
	Didecyl dimethyl ammonium chloride (Chloride didecyl dimethylammonium)	Drug
	Dioctyl dimethyl ammonium chloride (Chloride dioctyl dimethylammonium)	Drug
	Hexadecyl dimethyl benzyl ammonium chloride (Chloride hexadecyldimethylbenzyl ammonium)	Drug
	Hydrogen chloride (Hydrochloric acid)	Drug
	Methyl dodecyl benzyl trimethyl ammonium chloride (Chloride methyl dodecyl benzyl trimethyl ammonium)	Drug
	Octa decyl dimethyl benzyl ammonium chloride (Chloride octadecyl dimethylbenzyl ammonium)	Drug
	Octyl decyl dimethyl ammonium chloride (Chloride octyl dimethyl ammonium)	Drug
	Octyl dimethyl ammonium chloride (Chloride octyl dimethyl ammonium)	Drug
2- Labelling Standards
Analgesics	Acetaminophen	Drug
	Acetylsalicylic Acid	Drug
	Choline Salicylate	NHP
	Codeine	Drug
	Ibuprofen	Drug
	Magnesium Salicylate	NHP
	Sodium Salicylate	NHP
Anorectal Drug Products	Alcloxa	Drug
	Aluminum Hydroxide Gel	NHP
	Benzocaine	NHP
	Benzyl Alcohol	NHP
	Calamine	NHP
	Camphor	NHP
	Cocoa Butter	NHP
	Cod Liver Oil	NHP
	Dibucaine (hydrochloride)	Drug
	Dyclonine hydrochloride	Drug
	Epinephrine (hydrochloride)	NHP
	Ephedrine Sulphate	NHP
	Glycerine	NHP
	Hamamelis Water	NHP
	Juniper Tar	NHP
	Kaolin	NHP
	Lanolin	NHP
	Lidocaine	Drug
	Menthol	NHP
	Mineral Oil	Drug
	Petrolatum	Drug
	Phenylephrine Hydrochloride	Drug
	Pramoxine Hydrochloride	Drug
	Resorcinol	NHP
	Shark Liver Oil	NHP
	Tetracaine hydrochloride	Drug
	Topical Starch	NHP
	White Petrolatum	Drug
	Zinc Oxide	NHP
Antacid	Alginic acid/alginates (non-antacid)	NHP
	Aluminum Hydroxide	NHP
	Calcium Carbonate	NHP
	Dihydroxyaluminum Aminoacetate (Aluminum Glycinate)	NHP
	Dihydroxyaluminum Sodium Carbonate	NHP
	Glycine	NHP
	Magaldrate	NHP
	Magnesium Carbonate	NHP
	Magnesium Hydroxide	NHP
	Magnesium Oxide	NHP
	Magnesium Trisilicate	NHP
	Simethicone	Drug
	Sodium Bicarbonate	NHP
Anthelmintics	Piperazine Hexahydrate	Drug
	Pyrantel Pamoate	Drug
	Pyrvinium Pamoate	Drug
Antiflatulents	Activated Charcoal	Drug
	Simethicone	Drug
Antifungal, Topical	Calcium Undecylenate	NHP
	Copper Undecylenate	NHP
	Povidone Iodine	NHP
	Undecylenic Acid	NHP
	Zinc Undecylenate	NHP
Antifungal (Naftifine & Imidazole)	Clotrimazole Nitrate	Drug
	Miconazole Nitrate	Drug
	Naftifine Hydrochloride	Drug
Bismuth Subsalicylate	Bismuth Subsalicylate	Drug
Caffeine	Caffeine	NHP
Chamomile	Chamomillae romanae flos	NHP
Corn and Callus Removers	Salicylic Acid	NHP
Counterirritants	Allyl Isothiocyanate (Volatile Oil of Mustard)	NHP
	Ammonia Water	NHP
	Camphor	NHP
	Capsicin (as Capsaicin)	NHP
	Clove Oil	NHP
	Eucalyptus Oil and Eucalyptol	NHP
	Histamine Dihydrochloride	NHP
	Menthol	NHP
	Methyl Nicotinate	Drug
	Methyl Salicylate	NHP
	Thymol	NHP
	Turpentine Oil	NHP
Cyproheptadine	Cyproheptadine Hydrochloride Syrup	Drug
	Cyproheptadine Hydrochloride Tablets	Drug
	Cyproheptadine Tablets	Drug
Dental and Oral Care Products for Professional Use	Acidulated Phosphate Fluoride	NHP
	Aluminum Chloride	NHP
	Aluminum Potassium Sulfate	NHP
	Aluminum Sulfate	NHP
	Fluoride-Varnish	NHP
	Hemostatic Agents	NHP
	Racemic Epinephrine Hydrochloride	NHP
	Sodium Fluoride	NHP
	Stannous Fluoride	NHP
Dimenhydrinate	Dimenhydrinate	Drug
Echinacea Root	Root or rhizome of Echinacea augustifola, E. pallida or E. purpurea	NHP
Ephedra	E.antisyphilitica, E.equisetina, E.geradiana, E.intermedia, E.nevadensis, E. sinica, E.vulgaris	NHP
Ephedrine / Pseudoephedrine	dl-Ephedrine Hydrochloride	NHP
	dl-Ephedrine Sulphate	NHP
	d-Pseudoephedrine Hydrochloride	NHP
	d-Pseudoephedrine Sulphate	NHP
	l - Ephedrine Hydrochloride	NHP
	l - Ephedrine Sulphate	NHP
Ethylene Oxide Gaseous Sterilant	Ethylene oxide	Drug
Famotidine	Famotidine	Drug
Feverfew Leaf	Tanacetum parthenium	NHP
Fluoride containing treatment gels and rinses for consumer use	Acidulated Phosphate Fluoride	NHP
	Sodium Fluoride	NHP
	Stannous Fluoride	NHP
Homeopathic Preparations	Homeopathic preparations are Natural Health Products by definition according to Section 1 (1) of the NHP Regulations.
Hydrocortisone (topical)	Hydrocortisone	NHP at 0.5 %
	Hydrocortisone acetate	NHP at 0.5% hydrocortisone
Intestinal Flora Modifiers	Bifidobacterium bifidum	NHP
	B. breve	NHP
	B. longum	NHP
	Lactobacillus acidophilus	NHP
	L. bulgaricus	NHP
	L. casei	NHP
	L. helveticus	NHP
	L. rhamnosus	NHP
	Streptococcus thermophilus	NHP
Intravaginal	Clotrimazole	Drug
	Miconazole	Drug
	Tioconazole	Drug
Laxatives: Bulk-Forming	Bran	NHP
	Cellulose	NHP
	Karaya	NHP
	Malt Soup Extract	NHP
	Methylcellulose	Drug
	Polycarbophil	Drug
	Psyllium ingredients, including: Plantago ovata husks, Plantago seed, Psyllium (hemicellulose), Psyillium hydrophillic mucilloid, Psyllium seed, Psyllium seed (blond) and Psyllium seed husks	NHP
	Sodium Carboxymethylcellulose	Drug
Laxatives: Carbon Dioxide Releasing	Sodium Acid Pyrophosphate + Sodium Bicarbonate + Sodium Biphosphate	NHP
	Sodium Bicarbonate + Potassium Bitartrate	NHP
Laxatives: Hyperosmotic	Glycerine	NHP
	Sorbitol	NHP
Laxatives: Kit Bowel Cleansing System	Bisacodyl oral	Drug
	Bisacodyl suppository	Drug
	Magnesium Citrate	NHP
Laxatives: Lactulose	Lactulose	Drug
Laxatives: Lubricant	Mineral Oil (Heavy)	Drug
Laxatives: Saline	Magnesium Citrate	NHP
	Magnesium Hydroxide	NHP
	Magnesium Sulfate	NHP
	Sodium Biphosphate	NHP
	Sodium Phosphate	NHP
Laxatives: Stool Softener	Docusate Calcium	Drug
	Docusate Potassium	Drug
	Docusate Sodium	Drug
Laxatives: Stimulant	Aloe	NHP
	Bile Salts	NHP
	Bisacodyl	Drug
	Cascara sagrada ingredients, including: Casanthranol, Cascara fluid extract, aromatic Cascara sagrada bark,Cascara sagrada extract, Cascara sagrada fluid extract	NHP
	Castor Oil	NHP
	Dehydrocholic Acid	Drug
	Senna	NHP
	Sennosides A and B, including: Senna leaf powder, Senna fluid extract, Senna fruit extract, Senna syrup, Senna pod concentrate, Sennosides A and B crystalline	NHP
Lindane Lotion - Scabicide	Lindane (gamma benzene hexachloride)	Drug
Lindane Shampoo - Pediculicide	Lindane (gamma benzene hexachloride)	Drug
Mineral Supplements	Calcium	NHP
	Chlorine	NHP
	Chromium (III)	NHP
	Cobalt	NHP
	Copper	NHP
	Fluorine	NHP
	Iodine	NHP
	Iron	NHP
	Magnesium	NHP
	Manganese	NHP
	Molybdenum	NHP
	Nickel	NHP
	Phosphorous	NHP
	Potassium	NHP
	Selenium	NHP
	Silicon	NHP
	Sodium	NHP
	Sulphur	NHP
	Tin	NHP
	Vanadium	NHP
	Zinc	NHP
Nicotine Gum	Nicotine polacrilex	NHP
Nicotine Patches	Nicotine	NHP ≤ 22 mg/day
Non-Classical Antihistamines	Cetirizine	Drug
	Loratadine	Drug
Oral Potassium Supplements	Potassium Acetate	NHP
	Potassium Bicarbonate	NHP
	Potassium Chloride	NHP
	Potassium Citrate	NHP
	Potassium Gluconate	NHP
	Potassium Proteinate	NHP
Peppermint	Mentha piperita	NHP
Peroxide Oral Care Products	Carbamide Peroxide	NHP
	Hydrogen Peroxide	NHP
Poison Treatment	Activated Charcoal	Drug
	Ipecac Syrup	NHP
Quaternary Ammonium Compounds for Use Against HIV	All disinfectants are excluded from NHP Regulations by definition. See FDA definition of Drug 2 (c) - disinfectants distinguished from drugs for human use; F&D Regulations C.01.04.1(2)(g) compared to NHP 1.(1) definition of NHP - NHPs are always "for use in humans".
	Alkyl ethyl benzyl dimethyl ammonium chloride	Drug
	Aralkonium chloride (Alkyl dimethyl-3, 4- dichlorobenzyl ammonium chloride)	Drug
	Benzalkonium chloride (Alkyl dimethyl benzyl ammonium chloride)	Drug
	Cetalkonium chloride (Cetyl dimethyl benzyl ammonium chloride)	Drug
	Didecyl dimethyl ammonium chloride (Chloride didecyl dimethylammonium)	Drug
	Dioctyl dimethyl ammonium chloride (Chloride dioctyl dimethylammonium)	Drug
	Hexadecyl dimethyl benzyl ammonium chloride (Chloride hexadecyldimethylbenzyl ammonium)	Drug
	Methyl dodecyl benzyl trimethyl ammonium chloride (Chloride methyl dodecyl benzyl trimethyl ammonium)	Drug
	Octa decyl dimethyl benzyl ammonium chloride (Chloride octadecyl dimethylbenzyl ammonium)	Drug
	Octyl decyl dimethyl ammonium chloride (Chloride octyl dimethyl ammonium)	Drug
	Octyl dimethyl ammonium chloride (Chloride octyl dimethyl ammonium)	Drug
Sleep Aids	Diphenhydramine Citrate	Drug
	Diphenhydramine Hydrochloride	Drug
Topical Anaesthetic/ Analgesic/ Antipruritic	Allantoin	NHP
	Aluminum Hydroxide Gel	NHP
	Benzocaine	NHP
	Benzyl Alcohol	NHP
	Butamben picrate	Drug
	Calamine	NHP
	Camphor	NHP
	Camphorated Metacresol	Drug
	Cocoa Butter	NHP
	Dibucaine (or Dibucaine HCl)	Drug
	Dimethicone	Drug
	Dimethisoquin HCl	Drug
	Diphenhydramine HCl	Drug
	Dyclonine HCl	Drug
	Glycerine	NHP
	Juniper Tar	NHP
	Kaolin	NHP
	Lidocaine (or Lidocaine HCl)	Drug
	Menthol	NHP
	Petrolatum	Drug
	Phenol	NHP
	Phenolate Sodium	NHP
	Pramoxine HCl	Drug
	Resorcinol	NHP
	Shark Liver Oil	NHP
	Tetracaine (or Tetracaine HCl)	Drug
	Tripelennamine HCl	Drug
	White Petrolatum	Drug
	Zinc Acetate	NHP
	Zinc Carbonate	NHP
	Zinc Oxide	NHP
Topical Antibiotics	Antibiotics are drugs by definition: NHP Regulations Schedule 2.
	Bacitracin	Drug
	Bacitracin Zinc	Drug
	Gramicidin	Drug
	Mupirocin	Drug
	Polymixin B Sulfate	Drug
Triethanolamine Salicylate (Trolamine)	Triethanolamine Salicylate (TEAS)	Drug
Ubiquinone	Coenzyme Q10	NHP
Valerian	Valerian officinalis	NHP
Vitamin Supplements	Beta-carotene	NHP ≤ 10 000 IU/day of Vitamin A equivalents
	Biotin	NHP
	D-Pantothenic Acid or Pantothenic Acid	NHP
	Folic Acid	NHP ≤ 1 mg/day
	Niacin or Nicotinic Acid	NHP
	Niacinomide or Nicotinamide	NHP
	Vitamin A	NHP ≤ 10 000 IU/day
	Vitamin B1 Thiamine or Thiamine Hydrochloride	NHP
	Vitamin B2 or Riboflavin	NHP
	Vitamin B6, Pyridoxine or Pyridoxine Hydrochloride	NHP
	Vitamin B12 or Cyanocobalamin	NHP
	Vitamin C or Ascorbic Acid	NHP
	Vitamin D (Vitamin D2 or Vitamin D3)	NHP ≤ 1 000 IU/day
	Vitamin E	NHP
Wart Remover	Salicylic Acid	NHP