VANILLA CREAM (ANTIBACTERIAL GEL HAND WASH) LIQUID [BRANDS INTERNATIONAL]

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VANILLA CREAM (ANTIBACTERIAL GEL HAND WASH) LIQUID [BRANDS INTERNATIONAL]
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NDC 50157-113-14
Set ID ae7423dd-f62a-40ba-8e7b-3a28cdabf617
Category HUMAN OTC DRUG LABEL
Packager Brands International
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Drug Facts

    Active Ingredients

    Triclosan 0.115%

  • Purpose

    Antibacterial

  • Uses

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops.

  • WHEN USING

    When using this product do not get into eyes. If contact occurs, rinse eye thoroughly with water.

  • 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.

  • Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse
  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Sodium Chloride, DMDM Hydantoin, Citric Acid, Fragrance, EDTA, Yellow # 5, Red # 33

  • Package Label

    Vanilla Cream Hand Wash

    Antibacterial


    Refill

    14 oz / 414ml

    Hand Soap

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    VANILLA CREAM 
    antibacterial gel hand wash liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-113-14414 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)10/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2015
    Labeler - Brands International (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International243748238manufacture(50157-113)
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