ACNE FACE AND BODY- benzoyl peroxide shampoo, suspension

Acne Face and Body by

Drug Labeling and Warnings

Acne Face and Body by is a Otc medication manufactured, distributed, or labeled by Face Reality, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

For the treatment of Acne

Uses

Adults and children 12 years and over:

• For the treatment of acne.
• For acne-prone or oily skin.

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with eyes and eyelids. This product may cause irritation. Mild irritation may be reduced by using the product less frequently. If irritation becomes severe, discontinue use and consult a doctor.

Do not use

this medication if you have very sensitive skin or if you are sensitive to benzoly peroxide.

Keep out of reach of children.

Directions

Use 1 to 3 times daily on affected skin, work into lather, rinse off thoroughly.

Other Information

May bleach hair or fabrics. Store at room temperature. Keep away from heat or direct sunlight.

Inactive Ingredients

Purified Water, Ammonium Lauryl Sulfate, Glycerin, Cellulose Acetate, Disodium Cocoamphodiacetate, Propylene Glycol, Carbomer, Sodium Hydroxide, Fragrance.

Package Labeling:

INGREDIENTS AND APPEARANCE

ACNE FACE AND BODY 
benzoyl peroxide shampoo, suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70707-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70707-101-06	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2016
2	NDC: 70707-101-01	180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2011	09/15/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/15/2011

Labeler - Face Reality, Inc. (602958071)