XTRACARE ANTIBACTERIAL HAND CLEANSE FRESH CITRUS- 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

Fresh Citrus Scent

• Kills the germs
• Eliminates bacteria on hands
• Moisturizes the skin

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 handwashing to decrease bacteria on the skin.

WARNINGS

Warnings

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 Ingredientsi

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 blue no. 1, fd&c yellow no. 5.

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  FRESH CITRUS
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3.3 mg  in 221 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 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: 57337-069-01	221 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(57337-069)