Label: ANTIBACTERIAL HAND SANITIZER- ethyl alcohol spray

  • 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 July 30, 2014

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Uses

    Antibacterial hand sanitizer

  • Warnings

    Flammable, keep away from open flame. For external use only.

  • Directions

    Spray small amount in your palm and briskly rub hands together until dry.

  • Inactive Ingredients

    Carbomer, Fragrance, Glycerin,Propylene Glycol, Tocopheryl Acetate, Triethanolamine,Water

  • Questions 

    call 1-855-755-5346

  • Packaging

    Hand sanitizer

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-111
    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
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76138-111-0620 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/30/2014
    Labeler - Innovation Specialties (030837314)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Dowland Daily Health Co., Ltd421264675manufacture(76138-111)