BENZOYL ACNE WASH -2.5% BENZOYL PEROXIDE- benzoyl peroxide soap

Benzoyl Acne Wash -2.5% Benzoyl Peroxide by

Drug Labeling and Warnings

Benzoyl Acne Wash -2.5% Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by Only Yourx, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions: use 1 to 3 times daily for oily skin and scalp; apply with fingertips, using circular motion; gently scrub into a lather; rinse off thoroughly with warm water; if going outside, use a sunscreen

WARNINGS

Warnings: For External Use Only

INACTIVE INGREDIENT

Inactive Ingredients: Water, Sodium C14-16 Alpha Olefin Sulfonate, Disodium Cocoamyphodiacetate, Glycerin, Ethoxydiglycol, Cocoamidopropyl Betaine, Acrylates C10-20 Alkyl Acrylates Crosspolymer, Disodium EDA, Potassium Sorbate, Polysorbate 20, Sodium Hydroxide, Polyacrylmide, C13-14 Isoparaffin, Laureth-7, Ethylhexylglycerin, Phenoxyethanol

INDICATIONS & USAGE

Uses: treats acne and helps prevent new acne blemishes from forming; kills acne bacteria

PURPOSE

Treats acne and prevents new acne blemishes from forming

ACTIVE INGREDIENT

Active Ingredients: Benzoyl Peroxide 2.5%

KEEP OUT OF REACH OF CHILDREN

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

ASK DOCTOR

Consult a doctor: if excessive irritation occurs

OTHER SAFETY INFORMATION

Other Information: store at room temperature; keep tightly closed

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZOYL ACNE WASH -2.5% BENZOYL PEROXIDE 
benzoyl peroxide soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70367-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
GLYCERIN (UNII: PDC6A3C0OX)
ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70367-009-04	120 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
2	NDC: 70367-009-08	240 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
3	NDC: 70367-009-75	22.2 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/26/2014

Labeler - Only Yourx, Inc. (089207519)