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Compliances

Acne Therapy

• Benzoyl peroxide: 2.5 - 5.0%
• Salicylic acid: 0.5 - 3.5%

Analgesic, Anesthetic, Antipruritic

• Camphor: 0.1 - 3%
• Juniper tar: 1 - 5%
• Menthol: -.1 - 1%

Anorectal Drug Products

• Local Anesthetics
• Benzocaine: 5 - 20%
• Benzyl alcohol: 1 - 4%
• Dibucaine (hydrochloride): 0.25 - 1%
• Dyclonine hydrochloride: 0.5 - 1%
• Lidocaine: 2 - 5%
• Pramoxine hydrochloride: 1%
• Tetracaine (hydrochloride): 0.5 - 1%

Antacids–Maximum Dosages

(The minimum recommended dosage must provide a minimum acid neutralising capacity (ANC) of 5 mEq and result in a pH of 3.5 or greater at the end of the initial ten minute period as measured by the procedure outlined in the United States Pharmacopeia / National Formulary. Evidence that a product meets this standard must be available on request.)

• Aluminum hydroxide: 10000 mg
• Calcium carbonate: 8000 mg
• Dihydroxyaluminum aminoacetate: 4000 mg
• Dihydroxyaluminum sodium carbonate: 8016 mg
• Glycine: 8000 mg
• Magnesium carbonate: 3288 mg
• Magnesium hydroxide: 7200 mg
• Magnesium oxide: 1920 mg
• Magnesium trisilicate: 4680 mg
• Magaldrate: 10800 mg
• Sodium bicarbonate: 6000 mg

Combination non-antacid ingredients (Maximum Dosages)

• Alginic acid: 4000 mg
• Simethicone: 640 mg
• Calcium: 1500 mg per day
• Magnesium: 500 mg per day

Astringent

• Calamine, 5 - 25% concentration by weight per dosage unit (based on the zinc oxide content of calamine)
• Hamamelis weater, NF, 10 - 50%
• Zinc oxide: 5 - 25% by weight per dosage unit

Dental and Oral Care Products for Professional Use

• Acidulated Phosphate Fluoride
• Treatment rinse/gel: 0.02 (200 ppm fluoride ion) - 12,400 ppm, 1.24% fluoride ion equivalent
• For these products, the acidifying agent (acid) and the sodium/hydrogen fluoride are considered to be medicinal ingredients. These ingredients should be declared in the quantitative declaration: Sodium fluoride, hydrogen fluoride, phosphoric acid, orthophosphoric acid, hydrofluoric acid
• Aluminum Sulfate
• Strip (cord): 0.57 mg/cm
• Liquid: 25% (used to saturate cord, pellets, etc.)
• Pellet: 2.5 mg
• Aluminum Potassium Sulfate (Alum)
• Strip (cord): 0.68 mg/cm
• Aluminum Chloride
• Strip (cord): 0.79 mg/cm Coil (cotton): 1.97 mg/cm
• Liquid: 25% (used to saturate cord, coil, pellets, etc.)
• Pellet: 2 mg
• Combinations of Medicinal Ingredients
• Fluoride
• Sodium Fluoride (0.69% - acidulated) and Stannous fluoride (1.64%) treatment rinse
• Sodium Fluoride (acidulated) and Stannous Fluoride Gel cavity and crown preparation (0.72% fluoride ion equivalent)
• Sodium Fluoride 0.42% and Strontium Chloride 3.96%
• Sodium Fluoride 1.09%, Stannous fluoride 0.40%, and hydrogen fluoride 0.14%
• Hemostatic Agents (Maximum Quantities)
• Racemic Epinephrine Hydrochloride
• Strip (cord): 0.78 gm/cm
• Coil (cotton): 1.18 mg/cm
• Liquid: 8% Used to saturated coil, pellet, etc).
• Pellet: 1.15 mg
• Hemostatic (Maximum Concentrations)
• Racemic Epinephrine Hydrochloride: 0.67 mg/cm (strip)
  Aluminum Potassium Sulfate: 0.37 mg/cm
• Aluminum Potassium Sulfate: 0.68 mg/cm (strip)
  Racemic Epinephrine Hydrochloride: 0.36 mg/cm
• Racemic Epinephrine Hydrochloride: 0.36 mg/cm (strip)
  Zinc Chloride: 0.22 mg/cm
• Zinc Phenolsulphonate 0.57 mg/cm (strip)
  Racemic Epinephrine Hydrochloride: 0.006 mg/cm
• Fluoride-Varnish
• Sodium fluoride liquid: 5% (2.26% fluoride ion equivalent)
• Difluorosilane (fluor silane) liquid: 5% (0.76% fluoride ion equivalent)
• Sodium Fluoride
• Dentifrice: 0.27 - 2.74% (1.24% fluoride ion equivalent)
• Treatment gel: 0.02 (twice daily) or 0.05 (once daily) - 2.74% (1.24% fluoride ion equivalent)
• Treatment rinse: 0.02 (twice daily) or 0.05 (once daily) or 0.2 (once weekly) - 2.74% (1.24% fluoride ion equivalent)
• Stannous Fluoride
• Treatment gel: 0.6% - 1.64% (0.4% fluoride ion equivalent)
• Treatment rinse: 0.1% - 1.64% (0.4 fluoride ion equivalent)

Keratolytic

• Alcloxa: 0.2 - 2%
• Resorcinol: 1 - 3%

Topical Antibiotics

• Benzocaine: 5 - 20 %
• Butamben picrate: 1%
• Dibucaine (hydrochloride): 0.25 - 1%
• Dimethisoquin hydrochloride: 0.3 - 0.5%
• Dyclonine hydrochloride: 0.5 - 1%
• Lidocaine (hydrochloride): 0.5 - 4%
• Pramoxine hydrochloride: 0.5 - 1%
• Tetracaine (hydrochloride): 1 - 2%

Skin Protectant Ingredients – Minimum Concentrations

• Allantoin: 0.5%
• Aluminum hydroxide gel: 0.15%
• Calamine: 1%
• Cocoa butter: 50%
• Dimethicone: 1%
• Glycerin: 20%
• Kaolin: 4%
• Petrolatum: 30%
• Shark liver oil: 3%
• White petrolatum: 30%
• Zinc acetate: 0.1%
• Zinc carbonate: 0.2%
• Zinc oxide: 1%

Skin Protectant Ingredients – Minimum Concentration 50%

• Aluminum hydroxide gel
• Cocoa butter
• Glycerine in a 20-45% (w/w) aqueous solution
• Kaolin
• Lanolin
• Mineral oil
• Petrolatum
• Topical starch
• White Petrolatum

Skin Protectant Ingredients – To be used only in combination with other protectant ingredients in accordance with above table

• Calamine (not to exceed 25% by weight per dosage unit–based on the zinc oxide content of calamine)
• Cod liver oil
• Shark liver oil
• Zinc oxide (not to exceed 25% by weight per dosage unit

Topical Anaesthetic/Analgesic/Antipruritic

• A) Amine and “Caine” -type
• Benzocaine: 5 - 20%
• Butamben picrate: 1%
• Dibucaine (hydrochloride): 0.25 - 1%
• Dimenthisoquin hydrochloride: 0.3 - 0.5%
• Dyclonine hydrochloride: 0.5 - 1%
• Lidocaine (hydrochloride): 0.5 - 5%
• Pramoxine hydrochloride: 0.5 - 1%
• Tetracaine (hydrochloride): 1 - 2%
• B) Alcohols and Ketones
• Benzyl alcohol: 10 - 33%
• Camphor: 0.1 - 3%
• Camphorated and Metacresol
• with Camphor: 3 - 10.8%
• with Metacresol: 1 - 3.6%
• Juniper tar: 1 - 5%
• Menthol: 0.1 - 1%
• Phenol: 0.5 - 1.5%
• Phenolate sodium: 0.5 - 1.5%
• Resorcinol: 0.5 - 3%
• C) Antihistamines
• Diphenhydramine hydrochloride: 1 - 2%
• Tripelennamine hydrochloride: 0.5 - 2%

Vasoconstrictor

• Ephedrine sulfate: 0.1 - 1.25%
• Epinephrine (hydrochloride): 0.005 - 0.1%
• Phenylephrine hydrochloride: 0.25%

For more information, visit the Canadian Food Inspection Agency Website

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FDA Import Compliance • Japan Import Testing • EU Compliance Import
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