Label: XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL- triclosan soap

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated September 13, 2019

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  • 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

    label image

  • INGREDIENTS AND APPEARANCE
    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)
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