GLYTONE ACNE- benzoyl peroxide gel 
Genesis Pharmaceutical, Inc.

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.

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Glytone Acne Gel Benzoyl Peroxide 10%

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Treatment

Use

  • For the treatment of acne.

Warnings

For external use only

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

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

  • irritation becomes severe

Keep out of reach of children

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

Directions

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

Inactive Ingredients

Carbomer, Imidazolidinyl Urea, Methylparaben, Triethanolamine, Water.

Principal Display Panel - 56 g Carton

GLYTONE

ACNE

treatment

acne gel

10% BENZOYL PEROXIDE

NET WT. 56 g /2 OZ.

PDP Carton
GLYTONE ACNE 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-209
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5.6 g  in 56 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
IMIDUREA (UNII: M629807ATL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-209-011 in 1 BOX
156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/01/201005/31/2017
Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 8/2015
Document Id: 47877df9-eba1-4a55-9191-5da1f39abbaf
Set id: 80e8c76c-ad80-41e2-8711-091868970564
Version: 5
Effective Time: 20150804
 
Genesis Pharmaceutical, Inc.