Glytone acne 3P

Dosage form: gel
Ingredients: Benzoyl peroxide 3mL in 60mL
Labeler: Genesis Pharmaceuticals
NDC Code: 64760-302

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-302
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl peroxide (BENZOYL PEROXIDE) Benzoyl peroxide3 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
C13-14 ISOPARAFFIN 
POLYETHYLENE GLYCOL 400 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
LAURETH-7 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:64760-302-011 TUBE (TUBE) in 1 CARTON
160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D10/15/2010
Labeler - Genesis Pharmaceuticals (117196928)
Registrant - Genesis Pharmaceuticals (117196928)
Establishment
NameAddressID/FEIOperations
Englewood Labs172198223manufacture

Revised: 04/2011
 
Genesis Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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