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Name:Benzoyl Peroxide
Manufacturer:Md Formulation
Category:Over-the-counter (OTC) Marketed Drugs


Benzoyl Peroxide 10&%

BENZOYL PEROXIDE   - benzoyl peroxide gel 
MD Formulation

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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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.

Label
U Carton

BENZOYL PEROXIDE  
benzoyl peroxide gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66078-033
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 10 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBOMER 934  
PROPYLENE GLYCOL  
DIAZOLIDINYL UREA  
METHYLPARABEN  
PROPYLPARABEN  
AMINOMETHYLPROPANOL  
GLYCERIN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66078-033-02 54 CARTON ( CARTON) in 1 CASE contains a CARTON
1 1 CYLINDER ( CYLINDER) in 1 CARTON This package is contained within the CASE (66078-033-02) and contains a CYLINDER
1 61.68 g in 1 CYLINDER This package is contained within a CARTON and a CASE (66078-033-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 09/23/2001

Labeler - MD Formulation (087008363)
Registrant - Harmony Labs, inc. (105803274)
Establishment
Name Address ID/FEI Operations
Harmony Labs, inc. 105803274 manufacture, label, pack, relabel, repack

Revised: 05/2011 MD Formulation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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