Label: XTRACARE FOAMING FACIAL CLEANSER- triclosan gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 12, 2019

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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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