Label: HAND SANITIZER BOTTLE WITH CARABINER- alcohol 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 16, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 62%

  • PURPOSE

    Purpose

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children Children must be supervised in use of this product.

  • INDICATIONS & USAGE

    Directions

    Spread on both hands, rub in.

  • WARNINGS

    Warnings

    Flammable, keep away from fire or flame, For external use only.

  • DOSAGE & ADMINISTRATION

    Spread on both hands, rub in, let dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Triethanolamine, Glycerin, Propylene Glycol, Tocopheryl Acetate, Aloe Barbadensis Gel, Carbomer, Fragrance.

  • QUESTIONS

    Questions ?

    Call 1-855-755-5346

  • PRINCIPAL DISPLAY PANEL

    product label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER BOTTLE WITH CARABINER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76138-107-0330 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/15/2013
    Labeler - INNOVATION SPECIALTIES (030837314)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO CLEANER BIO-TECHNOLOGY CO.LTD527983808manufacture(76138-107)
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