Label: ANTI-BACTER HAND SANITIZER 70 ETHYL ALCOHOL MANGO- 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 8, 2021

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  • Drug Facts

  • Active Ingredient

    Ethyl alcohol 70% v/v

    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

    Keep out of reach of children.

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

    stop using and ak a doctor 

    if irritation or redness develops or lasts

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

    • place enough gel in your palms to thoroughly cover hand, rub hands together brikly 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:

    AQUA (WATER), GLYCERIN, ALOE BARBADENSIS LEAF JUICE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER / CARBOMER*, MANNITOL, MICROCRYSTALLINE CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, ALOE BARBADENSIS LEAF JUICE POWDER, TOCOPHERYL ACETATE, ALGIN, PARFUM, AMINOMETHYL PROPANOL, BENZOPHENONE-3, POTASSIUM SORBATE, SODIUM BENZOATE, LINALOOL, LIMONENE, EUGENOL, CINNAMAL, BENZYL SALICYLATE, CI 74260, CI 77492, CI 17200, CI 19140.
    *The letter next to the batch number means:
    A-acrylates/C10-30 alkyl acrylate crosspolymer B-carbomer

  • Package Lableing:

    Label2

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTER HAND SANITIZER 70 ETHYL ALCOHOL MANGO 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80457-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80457-003-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2021
    Labeler - ADEX COSMETICS & PHARMA LESZEK SIERDZINSKI (366050458)
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