OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL- salicylic acid gel

Oil-Free Foaming Acne Wash Facial Cleanser by

Drug Labeling and Warnings

Oil-Free Foaming Acne Wash Facial Cleanser 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 2.0% .......................... Acne Treatment

PURPOSE

XtraCare Oil-Free Foaming Acne Wash Facial Cleanser

WITH TEA TREE OIL

gentle cleansing for acne

Salicylic Acid 2% w/w

6 fl oz (177ml)

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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

INDICATIONS & USAGE

This XtraCare acne wash gently cleanses breakouts you already have and helps prevent them from returning. It works deep to clean and soothe without overdrying or irritating skin. Rinses clean, leaving no residue to clog pores.

WARNINGS

Warnings

For external use only. May stain some fabrics.

When using this product and other topical acne medications at the same time or immediately following use of this product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor.

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

Inactive Ingredients: water, sodium c14-16 sulfonate, cocamidopropyl betaine, acrylates copolymer, propylene glycol, sodium lauryl sulfate, fragrance, citric acid, aloe barbadensis leaf juice, disodium EDTA, sodium hydroxide, fd&c blue no. 1, fd&c yellow no. 5

OTHER SAFETY INFORMATION

Other information:

store at 20o to 25oC (68o to 77oF)

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

48235 BINGHAMPTON DR

NORTHVILLE, MI 48168 USA

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER  TEA TREE OIL
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	4 mg  in 177 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-034-01	177 mg in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/21/2013

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(57337-034)