GLYTONE ACNE 3P TREATMENT GEL- benzoyl peroxide gel 
Pierre Fabre USA Inc.

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Glytone Acne 3P Treatment Gel

Active IngredientPurpose

Benzoyl Peroxide 5% Acne Treatment

Acne treatment

Use

For the treatment of acne.

  • Dries and clears acne blemishes and allows skin to heal.
  • Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads
  • Helps prevent the development of new acne blemishes, blackheads, and whiteheads.

Warnings


For external use only.

Do not use

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

When using this product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

Stop use and ask a doctor if

  • irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

  • Cleanse the skin thoroughly before applying product.
  • Cover the affected area(s) with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by your doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

Other Information

Store at room temperature of 68-77°F (20-25°C).

Inactive ingredients

Water, polyacrylamide, C13-14 Isoparaffin, PEG-8/SMDI Copolymer, Phenoxyethanol, Caprylyl Glycol, Laureth-7, Citric acid

Acne 3PL Gel

Glytone Acne 3P Treatment Gel

5% micronized benzoyl peroxide

non-irritating formula

Net Wt. 56.7g / 2 oz.

GLYTONE ACNE 3P TREATMENT GEL 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-704
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.8 g  in 56.7 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LAURETH-7 (UNII: Z95S6G8201)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-704-011 in 1 CARTON10/15/2010
156.7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00610/15/201004/19/2023
Labeler - Pierre Fabre USA Inc. (117196928)

Revised: 11/2023
Document Id: 091bf671-be46-26fd-e063-6394a90afbc9
Set id: dab8b84c-beb4-4dd4-9137-020174d0a812
Version: 8
Effective Time: 20231101
 
Pierre Fabre USA Inc.