GLYTONE ACNE SELF CLEANSER  - salicylic acid aerosol, foam 
Glytone

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Glytone acne cleanse acne cleanser

Active ingredients            Purpose

Salicylic Acid 0.5%           Acne Treatment

Use:

• For the treatment of acne
• Clears up acne pimples, blackheads and whiteheads
• Helps keep skin clear of new acne blemishes and allows skin to heal.
  

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 a doctor.
  

Keep out of reach of children.

Directions:

• Use twice daily, AM and PM, or as directed by your physician. Cover entire face or infected area with a thin layer and allow to foam. Rinse thoroughly with warm water. For a masque-like effect, leave on for 30 seconds before rinsing.
• If going outside, use a sunscreen.
  

Water, Butylene Glycol, Methyl Perfluorobutyl her, Ether, Butylene Glycol, Methyl Perfluorobutyl Ether, Sorbitol, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Chondrus Crispus (carrageenan), Cyclopentasiloxane, Cyclohexasilioxane,Cocamide DEA, Polyhydroxystearic acid, Isononyl Isononanoate, Phenoxyethanol, Ethylhexyl Isononanoate, Methylparaben, Sodium Cocamidopropyl, PG-Dimonium Chloride Phosphate, Xanthan Gum,Sodium Hydroxide, Imidazolidinyl Urea, Tetrasodium EDTA, Ethylparaben, Butylparaben, Cinnamomum Zeylanicum Bark Extract, Propylparaben Isobutyparaben, Yeast Polysaccharides, Oryza Sativa (Rice) Bran extract, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090)

Use:

    * For the treatment of acne
    * Clears up acne pimples, blackheads and whiteheads
    * Helps keep skin clear of new acne blemishes and allows skin to heal.

Glytone acne cleanse

acne self-foaming cleanser

salicylic acid

non-irritating formula

100 ml/3.4 fl oz

GLYTONE ACNE SELF CLEANSER  salicylic acid   aerosol, foam

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 64760-301 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic acid (Salicylic acid) Salicylic acid .5 mL  in 100 mL

Inactive Ingredients Ingredient Name Strength Water   ETHER   BUTYLENE GLYCOL   SORBITOL   BETAINE   SODIUM LAURETH SULFATE   CARRAGEENAN   CYCLOMETHICONE 5   CYCLOMETHICONE 6   COCO DIETHANOLAMIDE   ISONONYL ISONONANOATE   PHENOXYETHANOL   ETHYLHEXYL ISONONANOATE   METHYLPARABEN   XANTHAN GUM   SODIUM HYDROXIDE   IMIDUREA   EDETATE SODIUM   BUTYLPARABEN   PROPYLPARABEN   ISOBUTYLPARABEN   YEAST   RICE BRAN   METHYLCHLOROISOTHIAZOLINONE   METHYLISOTHIAZOLINONE   FD&C BLUE NO. 1

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64760-301-01 1 BOTTLE In 1 CARTON contains a BOTTLE, PUMP 1 100 mL In 1 BOTTLE, PUMP This package is contained within the CARTON (64760-301-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/12/2010

Labeler - Glytone (117196928)

Establishment
Name	Address	ID/FEI	Operations
Genesis Pharmaceutical		117196928	manufacture

Revised: 10/2010Glytone