XTRACARE DEEP CLEANING ASTRINGENT- salicylic acid gel

XtraCare Deep Cleaning Astringent by

Drug Labeling and Warnings

XtraCare Deep Cleaning Astringent 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 Medication

PURPOSE

XtraCare (salicylic acid) deep cleaning astringent

• cleans deep
• treats acne
• helps prevent pimples

Compare to Clean & Clear® Deep Cleaning Astringent

8 fl. oz. (237 mL)

salicylic acid deep cleaning astringent

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

INDICATIONS & USAGE

Use  for the treatment of acne

WARNINGS

Warnings For external use only

Flammable, keep away from open flame

When using this product

• avoid contact with eyes. If contact occurs, immediately flush with water.
• using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

DOSAGE & ADMINISTRATION

Directions

• cleanse the skin thoroughly before applying medication
• moisten a cotton ball or pad cover the entire
• affected rea with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a physician. If bothersome drying or peeking occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT

Inactive Ingredients

water, alcohol, PEG-40 hydrogenated castor oil, fragrance, aloe barbadensis leaf juice, d&c red no.33

OTHER SAFETY INFORMATION

*This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®deep cleansing astringent.

DISTRIBUTED BY: 

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168 USA

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE DEEP CLEANING ASTRINGENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 237 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-035-01	237 mg in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/26/2013

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(57337-035)