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

Drug Label Information

Updated February 28, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient                                    Purpose

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

  • PURPOSE

    Uses

    for hand washing to decrease bacteria on the skin.

  • 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

    Antibacterial Moisturizing Hand Soap

    Mountain Spring Scent

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

  • 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  MOUNTAIN SPRING
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3.3 mg  in 221 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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-020-01221 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 DrugM00309/03/2013
    Labeler - Rejoice International, Inc. (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-020)
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