Benzoyl Peroxide by MD Formulation / Harmony Labs, inc. BENZOYL PEROXIDE gel

Benzoyl Peroxide by

Drug Labeling and Warnings

Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by MD Formulation, Harmony Labs, inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzoyl Peroxide 10%

PURPOSE

Acne Treatment

INDICATIONS & USAGE

Treats and helps prevent acne pimples.

WARNINGS

Foe external use only

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE  
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66078-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66078-033-02	54 in 1 CASE
1		1 in 1 CARTON
1		61.68 g in 1 CYLINDER

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	Business Operations
Harmony Labs, inc.		105803274	manufacture, label, pack, relabel, repack