XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL- triclosan soap

XtraCare Antibacterial Hand Cleanse by

Drug Labeling and Warnings

XtraCare Antibacterial Hand Cleanse by is a Otc medication manufactured, distributed, or labeled by Rejoice International, Inc., China Ningbo Shangge Cosmetic Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                 Purpose

Triclosan 0.15%................................Antibacterial

PURPOSE

Antibacterial moisturizing Hand Soap

Original

Kills the Germs

Elimiates bacteria on hands

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

Uses

for hand washing to decrease bacteria on the skin.

WARNINGS

Warnings

for external use only

When using this product avoid contact with eyes.  In case of eye contact, flush with water.

Stop use and ask a doctor if irritation and redness develops.

DOSAGE & ADMINISTRATION

Directions

• pump into hands
• lather vigorously for at least 15 seconds
• rinse and dry thoroughly.

INACTIVE INGREDIENT

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone, fd&c yellow no. 5, d&c red no. 33.

OTHER SAFETY INFORMATION

Other information

• store at room temperature

DISTRIBUTED BY:

REJOICE INTERNATIONAL, INC.

48325 BINGHAMPTON DR., NORTHVILLE, MI 48168, USA

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE ANTIBACTERIAL HAND CLEANSE  ORIGINAL
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	6.6   in 443 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
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: 57337-022-01	443 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/03/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/03/2013

Labeler - Rejoice International, Inc. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(57337-022)