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XtraCare Antibacterial Hand Cleanse Original

Medically reviewed on September 25, 2017

Dosage form: soap
Ingredients: TRICLOSAN 3.3mg in 221mL
Labeler: Rejoice International, Inc.
NDC Code: 57337-021

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.

Active Ingredient                         Purpose

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

Antibacterial Moisturizing Hand Soap

Original

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

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

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

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

  • store at room temperature

DISTRIBUTED BY:

REJOICE INTERNATIONAL, INC.

48325 BINGHAMPTON DR.,

NORTHVILLE, MI 48168, USA

MADE IN CHINA

XTRACARE ANTIBACTERIAL HAND CLEANSE  ORIGINAL
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-021
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN3.3 mg  in 221 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C14-16 OLEFIN SULFONATE 
SODIUM LAURETH SULFATE 
COCO DIETHANOLAMIDE 
PEG-150 DISTEARATE 
SODIUM CHLORIDE 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
EDETATE DISODIUM 
ALOE VERA LEAF 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:57337-021-01221 mL in 1 BOTTLE
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/FEIOperations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-021)

 
Rejoice International, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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