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Benzoyl Peroxide by MD Formulation

Medically reviewed on May 18, 2018

Dosage form: gel
Ingredients: BENZOYL PEROXIDE 10g in 100g
Labeler: MD Formulation
NDC Code: 66078-033

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.

Benzoyl Peroxide 10&%

Benzoyl Peroxide 10%

Acne Treatment

Treats and helps prevent acne pimples.

Foe external use only

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

Directions Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1 to 3 times dally. Because excessive drying of the skin may accur, start with 1 application daily, then gradually increase to 2 to 3 times daily If needed or as directed by a
physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other other day.

Inactive Ingredients:
Water, glycerin, propylene glycol, carbomer, diazolidinyl urea, methylparaben, propylparaben, aminomethyl propanol.

BENZOYL PEROXIDE  
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-033
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER 934 
PROPYLENE GLYCOL 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
AMINOMETHYLPROPANOL 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:66078-033-0254 CARTON (CARTON) in 1 CASE
11 CYLINDER (CYLINDER) in 1 CARTON
161.68 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/23/2001
Labeler - MD Formulation (087008363)
Registrant - Harmony Labs, inc. (105803274)
Establishment
NameAddressID/FEIOperations
Harmony Labs, inc.105803274manufacture, label, pack, relabel, repack

 
MD Formulation

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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