XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL- triclosan soap 
Rejoice International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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XtraCare Antibacterial Hand Cleanse

Active Ingredient                                 Purpose

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

Antibacterial moisturizing Hand Soap

Original

Kills the Germs

Elimiates bacteria on hands

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

for hand washing to decrease bacteria on the skin.

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.

Directions

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 information

DISTRIBUTED BY:

REJOICE INTERNATIONAL, INC.

48325 BINGHAMPTON DR., NORTHVILLE, MI 48168, USA

MADE IN CHINA

label image

XTRACARE ANTIBACTERIAL HAND CLEANSE  ORIGINAL
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN6.6   in 443 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57337-022-01443 mL in 1 BOTTLE; Type 0: Not a Combination Product09/03/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/03/2013
Labeler - Rejoice International, Inc. (078741245)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-022)

Revised: 9/2019
Document Id: 926fa735-4a5b-981e-e053-2995a90a7da9
Set id: 3569e2e0-c886-49ae-8237-0e838081909c
Version: 4
Effective Time: 20190913
 
Rejoice International, Inc.