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acne treatment by Glytone

Dosage form: gel
Ingredients: benzoyl peroxide 5.6g in 56g
Labeler: Glytone
NDC Code: 64760-209

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 Treatment Acne


Active Ingredients   purpose
benzoyl peroxide 10%   Acne treatment



Stop use and ask a doctor if rash or irritation develops and lasts



When using this product

avoid unnecessary sun exposure and use a sunscreen

using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor

avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

flammable-keep away from open fire or flame



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.



Directions

Cleanse the skin thoroughly prior to applying

Cover the 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, use a sunscreen Allow Acne Gel to dry, then follow directions i the sunscreen labeling If sensitivity develops, discontinue use of both products and consult a doctor.


Use

For the treatment of acne



Glytone Acne

treatment acne gel

10% benzoyl peroxide

Net wt. 2oz (56 g)

Inactive ingredients: Carbomer, Imidazolidinyl Urea, Methylparaben, Triethanolamine, Water (Aqua)



Warnings

For external use only


Directions

Cleanse the skin thoroughly prior to applying

Cover the 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, use a sunscreen. Allow Acne Gel to dry, then follow directions in the sunscreen labeling. If sensitivity develops, discontinue use of oth products and consult a doctor.


ACNE TREATMENT  
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-209
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzoyl peroxide (benzoyl peroxide) benzoyl peroxide5.6 g  in 56 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
IMIDUREA 
METHYLPARABEN 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:64760-209-011 TUBE (TUBE) in 1 BOX
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D03/01/2010
Labeler - Glytone (117196928)

Revised: 01/2011
 
Glytone

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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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