Label: HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 June 30, 2020

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  • ACTIVE INGREDIENT

    Active ingredients

    Ethyl Alcohol 62%

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses hand sanitizer to help reduce bacteria on the skin . For occassional and personal domestic use

  • WARNINGS

    Warnings

    for external use only: hands

    Flammable. Keep away from fire or flame

  • WHEN USING

    when using this product, avoid contact with eyes, in case of contact, rinse eyes thoroughly with water, avoid contact with broken skin .

  • STOP USE

    Stop use and consult a doctor if . irritation or redness develops. condition persists for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. children under 6, use only under adult supervision, Not recommended for infants.

    For external use only. Do not drink.
    If swallowed, seek professional assistance or contact a poison control center.

  • DOSAGE & ADMINISTRATION

    Directions. Place enough product in your palm to thoroughly spread on both hands and rub into skin until dry.

  • STORAGE AND HANDLING

    Other information. do not store above 105°F， may discolor some fabics. harmful to wood finished and plastics

  • INACTIVE INGREDIENT

    Inactive ingredients acrylates/C10-C30 alkyl acrylate crosspolymer,aloe barbadensis leaf juice, glycerin, maltodextrin, propylene glycol, water , triethanolamine,Fragrance. FD&C Red No.4

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72264-028
    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
    TROLAMINE (UNII: 9O3K93S3TK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72264-028-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/29/2020
    Labeler - Biolab International Incorporated (200167919)
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