Canada Import Testing

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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