Label: XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL- triclosan soap 

  • NDC Code(s): 57337-022-01
  • Packager: Rejoice International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

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  • ACTIVE INGREDIENT

    Active Ingredient                                 Purpose

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

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  • PURPOSE

    Antibacterial moisturizing Hand Soap

    Original

    Kills the Germs

    Elimiates bacteria on hands

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  • 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.

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  • INDICATIONS & USAGE

    Uses

    for hand washing to decrease bacteria on the skin.

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions

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

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  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature
    DISTRIBUTED BY: REJOICE INTERNATIONAL, INC. 48325 BINGHAMPTON DR., NORTHVILLE, MI 48168, USA MADE IN CHINA Close
  • INGREDIENTS AND APPEARANCE
    XTRACARE ANTIBACTERIAL HAND CLEANSE  ORIGINAL
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57337-022
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 6.6   in 443 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM C14-16 OLEFIN SULFONATE  
    SODIUM LAURETH SULFATE  
    COCO DIETHANOLAMIDE  
    SODIUM CHLORIDE  
    PEG-150 DISTEARATE  
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    EDETATE DISODIUM  
    ALOE VERA LEAF  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    FD&C YELLOW NO. 5  
    D&C RED NO. 33  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57337-022-01 443 mL in 1 BOTTLE
    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)
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