GLYTONE ACNE 3P  - benzoyl peroxide gel 
Glytone

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Glytone acne 3P

Active Ingredients       Purpose

Benzoyl Peroxide 5%     Acne Treatment

Acne treatment

Use:

For the treatment of acne

Clears up acne pimple, blackheads and whiteheads

Helps keep skin clear of new acne blemishes and allows skin to heal

Keep out of reach of children

Inactive ingredients: Water (aqua), polyacrylamide, C13-14 Isoparaffin, PEG-8/SMDI Copolyer, Phenoxyethanol, Caprylyl Glycol, Laureth-7, Citric acid

Directions:

Cleanse the skin thoroughly before applying medication. Cover the entire affected area 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 physician

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Warnings:
For external use only. Using other topical acne medications at the same time or immediately following use of the product may cause increased dryness or irritation of the skin. If this occurs,only one medication should be used unless directed by your physician. If going outside use a sunscreen.
When using this product
this product may bleach hair or dyed fabric. Avoid contact with clothing; may cause discoloration. Avoid unnecessary sun exposure and use a sunscreen. Avoid contact with eyes, lips and mouth.
Do not use if you have very sensitive skin
are sensitive to benzoyl peroxide

Glytone acne 3P uses a unique patent pending formulation associating a liquid matrix of micronized benzoyl peroxide with polyolprepolymers to help control the delivery of the acne treatment while minimizing potential irritation. The innovative hydro-gel matrix provides time extended active delivery and optimal skin hydration.

Glytone Acne

treat acne 3P gel

5% micronized benzoyl peroxide

1.0 polyolprepolymer

non-irritating formula

60 ml/2 fl. oz

GLYTONE ACNE 3P  benzoyl peroxide   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 64760-302 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl peroxide (BENZOYL PEROXIDE) Benzoyl peroxide 3 mL  in 60 mL

Inactive Ingredients Ingredient Name Strength WATER   C13-14 ISOPARAFFIN   POLYETHYLENE GLYCOL 400   PHENOXYETHANOL   CAPRYLYL GLYCOL   LAURETH-7   CITRIC ACID MONOHYDRATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64760-302-01 1 TUBE In 1 CARTON contains a TUBE 1 60 mL In 1 TUBE This package is contained within the CARTON (64760-302-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333D	10/15/2010

Labeler - Glytone (117196928)

Establishment
Name	Address	ID/FEI	Operations
Genesis Pharmaceuticals		117196928	manufacture

Revised: 10/2010Glytone