Label: ANTI BACTER HAND SANITIZER MED CLEAN NO WATER NEEDED WITH ALOE VERA AND GLYCERINE- alcohol 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 March 25, 2021

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  • Drug Facts

  • Active Ingredient

    Ethyl alcohol 70%

    Purpose

    Antiseptic

  • Uses

    • for travel, shopping, school, work and home use
    • to help reduce bacteria on the skin
    • for use when water and soap are not available
    • recommended for repeated uses
  • Warnings:

    For External use only: hands

    • flammable, keep away from sources of heat or fire
    • do not use on broken, cut or irritated skin

    When using this product

    • avoid contact with eyes, if contact occurs, rinse thoroughly with water, 

    stop using and ak a doctor

    if irritation or redness develops or lasts 

    keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    • place enough gel in your palms to thoroughly cover your hands, rub hands together briskly until dry
    • children under 6 years of age should be supervised when using Anti-Bacter Hand Sanitizer
    • not recommended for infants
  • Other information

    • store at a temperature below 104°F (40°C)
    • may discolor certain fabrics and surfaces
  • Inactive ingredients:

    Water, Glycerin, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl acrylate crosspolymer/carbomer*, mannitol, microcrystaline cellylose, hydroxypropyl methylcallulose, aloe barbadensis leaf juice powder, tocopheryl acecate, algin, parfum (fragrance), aminomethyl propanol, benzophenone-3, potassium sorbate, sodium benzoate, CI 74260, CI 77492 ( Iron Oxide), CI 19140 (FD&C Yellow 5), CI 42090 (Blue 1).

    *The letter next to the batch number means:

    A- acrylates/C1O-3O alkyl acrylate crosspolymer B-carbomer

  • Package Labeling:

    002

  • INGREDIENTS AND APPEARANCE
    ANTI BACTER HAND SANITIZER MED CLEAN NO WATER NEEDED WITH ALOE VERA AND GLYCERINE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80457-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80457-001-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/11/2020
    Labeler - ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI (366050458)
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