GLYTONE ACNE 3P TREATMENT GEL- benzoyl peroxide gel

Glytone Acne 3P Treatment Gel by

Drug Labeling and Warnings

Glytone Acne 3P Treatment Gel by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active IngredientPurpose

Benzoyl Peroxide 5% Acne Treatment

PURPOSE

Acne treatment

INDICATIONS & USAGE

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

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 INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

Glytone Acne 3P Treatment Gel

5% micronized benzoyl peroxide

non-irritating formula

Net Wt. 56.7g / 2 oz.

INGREDIENTS AND APPEARANCE

GLYTONE ACNE 3P TREATMENT GEL 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.8 g  in 56.7 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-704-01	1 in 1 CARTON	10/15/2010
1		56.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/15/2010

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)