XTRACARE FOAMING FACIAL CLEANSER- triclosan gel

XtraCare Foaming Facial Cleanser by

Drug Labeling and Warnings

XtraCare Foaming 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

Triclosan 0.25% ........................... Antiseptic

PURPOSE

XtraCare (oil-free) foaming facial cleanser

medicated to kill problem-causing bacteria without overdrying

Compare to Clean & Clear® Foaming Facial Cleanser

8 fl. oz. (237 mL)

oil free foaming facial cleanser

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

Use  to help reduce bacteria on the skin

WARNINGS

Warnings For external use only

When using this product avoid contact with eyes.  if eye contact occurs, immediately flush with water.

Stop use and ask a doctor if

• excessive skin irritation develops or condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

DOSAGE & ADMINISTRATION

Directions

mix in hands with water. Work into a foamy later. Smooth over face and neck. Rinse thoroughly.

OTHER SAFETY INFORMATION

Other Information

Do not store where water may enter bottle.

*This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®foaming facial cleanser.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168 USA

MADE IN CHINA

INACTIVE INGREDIENT

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, cocamide betaine, glycerin, PEG-40 hydrogenated castor oil, fragrance, DMDM hydantoin, disodium EDTA, citric acid, methylparaben, propylparaben, fd&c yellow no.5, d&c red no.33

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE FOAMING FACIAL CLEANSER 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1 mg  in 237 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
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: 57337-036-01	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 not final	part333A	11/26/2013

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(57337-036)