ACNE BODY WASH- salicylic acid gel

Acne Body Wash by

Drug Labeling and Warnings

Acne Body Wash by is a Otc medication manufactured, distributed, or labeled by Rejoice International, China Ningbo Shangge Cosmetic Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                     Purpose

Salicylic Acid 2% ............Acne Treatment

PURPOSE

XtraCare 

ACNE Body Wash

Salicylic Acid

Acne Medication

• helps to fight body acne
• for refresh & clean skin
• enriched with aloe vera

*Compare to Active Ingredients in Neutrogena Body Clear Body Wash

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

XtraCare Acne Body wash is refreshing, clean-rinsing body wash that helps fight acne on your back, chest, and shoulders. The foaming lather rinses completely without pore-clogging residue, leaving your skin feeling clean.

Use

for the treatment of acne.

DOSAGE & ADMINISTRATION

Directions: Use daily in the shower or bath.  For maximum lather, massage over wet skin with a washcloth or body puff, concentrating on areas prone to breakouts. Rinse well.

WARNINGS

Warning: for external use only.

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

When using this product avoid contact with eyes.  If contact occurs, flush thoroughly with water.

OTHER SAFETY INFORMATION

Other information: Store at room temperature.

*this product is not manufactured of distributed by Neutrogena Corp., owner of the registered trademark Body Clear® Body Wash.

Distributed By:

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168, USA

MADE IN CHINA

INACTIVE INGREDIENT

Inactive Ingredients: water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, disodium cocoamphodiacetate, glycerin, cocamide MEA, fragrance, citric acid, aloe barbadensis leaf extract, methylchloroisothiazolinone, methylisothiazoline, FD&C yellow no.5, D&C red no.33

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE BODY WASH 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	7 mg  in 354 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
GLYCERIN (UNII: PDC6A3C0OX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-030-01	354 mg in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/18/2013

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(57337-030)