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ARCHIVED 1. List D: List of certain non-prescription drugs for distribution as samples

The solidus (/) in column 6 indicates that the terms and/or the statements are synonymous. Either term or statement may be included on the label by the market authorization holder. Text in parentheses in column 6 is additional optional information which can also be added to the label at the market authorization holder's discretion.

Column 1
Class of Non-prescription Drugs		 Column 2
Medicinal Ingredient(s)		 Column 3
Quantity of Medicinal Ingredient(s)		 Column 4
Qualifier(s)		 Column 5
Route(s) of Administration		 Column 6
Permissible Use(s) or Purpose(s)		 Column 7
Last Revised (YYYY-MM-DD)
Mouthwashes Cetylpyridinium Chloride 0.05-0.075% For human use Dental, Gingival, Periodontal
  • Kills germs that cause bad breath
  • Helps prevent/reduce plaque and gingivitis
 2020-03-13
Personal Care Use Antiseptic Skin Cleansers Benzalkonium chloride 0.1-0.15% For human use Topical
  • Antiseptic (skin) cleanser
  • Medicated (skin) cleanser
  • Antibacterial (skin) cleanser
  • Kills harmful bacteria/germs
  • Effective in destroying (harmful) bacteria to provide antiseptic cleansing
  • For personal hand hygiene to help prevent the spread of bacteria
2020-03-13
Benzethonium chloride 0.05-0.5%
Chlorhexidine gluconate 2-4%
Chloroxylenol 0.5-3%
Triclosan 0.1-1%
Sunscreens Avobenzone ≤3%

For human use

The Sun Protection Factor (SPF) must be ≥2 and values greater than 50 must be declared as SPF 50+

 Topical
  • Sun Protection Factor "X" / SPF "X"
  • Helps prevent sunburn
  • Sunscreen
  • Sunburn protectant
  • Helps protect from sunburn
  • Broad spectrum (Sun Protection Factor "X" / SPF "X")
  • Filters/Screens UVA/UVB rays
  • Absorbs throughout the UVA/UVB spectrum to provide sunburn protection
  • UVA/UVB protection
  • Water/Sweat Resistant [40 minutes / 80 minutes]
 2020-03-13
Bemotrizinol ≤6%
Oxybenzone ≤6%
Sulisobenzone ≤10%
Dioxybenzone ≤3%
Bisoctrizole ≤5%
Cinoxate ≤3%
Diethanolamine methoxycinnamate ≤10%
Drometrizole trisiloxane ≤15%
Ecamsule ≤10%
Ensulizole ≤4%
Enzacamene ≤4%
Homosalate ≤15%
Meradimate ≤5%
Octinoxate ≤7.5%
Octisalate ≤5%
Octocrylene ≤10%
Padimate O ≤8%
Trolamine salicylate ≤12%
Anti-Dandruff Products Pyrithione zinc 0.1-0.25% (Leave on)
0.3-2% (Rinse off)		 For human use Topical
  • (For the relief of) / (Controls) / (Helps prevent) / (Helps prevent [the] recurrence of) / (Reduces [the] recurrence of) / (Reduces) dandruff / (and) (the symptoms of) ([skin / scalp] itching / irritation / redness / flaking [and]/ scaling) (associated with dandruff)
2020-03-13
Coal tar 0.5-5%
Coal tar + dl-Menthol / l-Menthol 1.8% Coal tar + 1.5% dl-Menthol / l-Menthol
(Rinse off)
Diaper Rash Products Dimethicone 1-30% For human use Topical
  • Helps prevent diaper rash
  • Protects chafed skin due to diaper rash
  • Helps protect from wetness that causes diaper rash
  • Temporarily protects and helps relieve minor skin irritation due to diaper rash
 2020-03-13
Mineral oil 50-100%
Petrolatum 30-100%
White petrolatum 30-100%
Medicated Skin Care Products Dimethicone 1-30% For human use Topical
  • Temporarily protects and helps relieve minor skin irritation and itching
  • Temporarily protects and helps relieve minor skin irritation and itching due to minor cuts, scrapes and burns
  • Temporarily protects and helps relieve minor skin irritation and itching due to (rashes)(and/ or)(eczema)         
2020-03-13
Mineral oil 50-100%
Petrolatum 30-100%
White petrolatum 30-100%
Acne Therapy Products Benzoyl peroxide 2.5-5% For human use Topical
  • For the treatment/management of acne
  • Helps treat acne pimples (and allows skin to heal)
  • Dries and helps clear up acne pimples (and allows skin to heal)
  • Reduces the number and/or severity of acne pimples (and allow skin to heal)
  • Penetrates pores to control/ reduce acne pimples
  • Helps keep skin clear of new acne pimples
  • Helps prevent new acne pimples from forming
  • Acne treatment
  • Helps prevent acne
  • Helps prevent acne pimples
  • Helps clear acne
  • Acne treatment/medication
  • Helps treat acne/pimples
  • Reduces the number of pimples
  • Prevents (and)/Kills acne bacteria
  • Eliminates acne bacteria
 2020-03-13
Throat Lozenges Dyclonine hydrochloride 1 – 3 mg per lozenge For human use Oral
  • For the temporary relief of (minor) sore throat
  • For temporary relief of pain of (minor) sore throat
  • Antiseptic
 2020-03-13
Hexylresorcinol 2 – 4 mg per lozenge
Cetylpyridinium chloride 1 – 2 mg per lozenge
Dequalinium chloride 0.25 mg per lozenge
Domiphen bromide 1.5 mg per lozenge
Athlete's Foot Treatments Chlorphenesin 0.5 – 1% For human use Topical
  • For the treatment of athlete's foot
  • Cures athlete's foot
  • Kills athlete's foot fungus
  • Relieves (itching, scaling, burning, cracking, redness, soreness, irritation) of athlete's foot
  • With daily use, for the prevention of athlete's foot, for individuals with recurring problems
 2020-03-13
Clioquinol 3%
Haloprogin 1%
Tolnaftate 1%

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