Label: XTRACARE ANTIBACTERIAL HAND CLEANSE MOUNTAIN SPRING- triclosan soap 

  • NDC Code(s): 57337-020-01
  • 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                                    Purpose

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

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  • PURPOSE

    Uses

    for hand washing to decrease bacteria on the skin.

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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

    Antibacterial Moisturizing Hand Soap

    Mountain Spring Scent

    • Kills the germs
    • Eliminates bacteria on hands
    • Moisturizes 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 blue no. 1.

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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

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  • INGREDIENTS AND APPEARANCE
    XTRACARE ANTIBACTERIAL HAND CLEANSE  MOUNTAIN SPRING
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57337-020
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 3.3 mg  in 221 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 BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57337-020-01 221 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(57337-020)
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