XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]

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XTRACARE FOAMING FACIAL CLEANSER (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]
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NDC 58503-036-01
Set ID 5b78fe93-31be-4bfe-88dd-cd310b9ba1f7
Category HUMAN OTC DRUG LABEL
Packager China Ningbo Shangge Cosmetic Technology Corp.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active Ingredient                          Purpose

    Triclosan 0.25% ........................... Antiseptic

  • PURPOSE

    XtraCare (oil-free) foaming facial cleanser

    medicated to kill problem-causing bacteria without overdrying

    Compare to Clean & Clear® Foaming Facial Cleanser

    8 fl. oz. (237 mL)

    oil free foaming facial cleanser

  • 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

    Use  to help reduce bacteria on the skin

  • WARNINGS

    Warnings For external use only

    When using this product avoid contact with eyes.  if eye contact occurs, immediately flush with water.

    Stop use and ask a doctor if

    • excessive skin irritation develops or condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • DOSAGE & ADMINISTRATION

    Directions

    mix in hands with water. Work into a foamy later. Smooth over face and neck. Rinse thoroughly.

  • OTHER SAFETY INFORMATION

    Other Information

    Do not store where water may enter bottle.

    *This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®foaming facial cleanser.

    DISTRIBUTED BY:

    REJOICE INTERNATIONAL INC.

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, sodium c14-16 olefin sulfonate, cocamide betaine, glycerin, PEG-40 hydrogenated castor oil, fragrance, DMDM hydantoin, disodium EDTA, citric acid, methylparaben, propylparaben, fd&c yellow no.5, d&c red no.33

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    XTRACARE FOAMING FACIAL CLEANSER 
    triclosan gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1 mg  in 237 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-036-01237 mg in 1 BOTTLE; Type 0: Not a Combination Product11/26/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/26/2013
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-036)
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