Label: VANILLA CREAM- antibacterial gel hand wash liquid

  • 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 October 31, 2015

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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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