Label: ANTIBACTERIAL HAND SANITIZER- 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 August 10, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Fact

  • Active Ingredient(s)

    Ethyl Alcohol 62%. 

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help decrease bacterial on the skkin when water, soap and towel are not available

    Recommended for repeated use

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame

    Do not apply around eyes. Do not use in ears and mouth.

  • WHEN USING

    When using this product, avoid contact with eyes.  In case of contact, flush eyes with water

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be spervised when use this product.

  • Directions

    Squirt as needed into your palms and thoroughly spread on both hands, rub into skin until dry.

  • Other information

    Store st 20C (68-77F)

    May discolor some fabrics

  • Inactive ingredients

    Water, glycerin, triethanolamine, carbomer, Vitamin E, aloe barbadensis leaf extract

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81131-001
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81131-001-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2021
    2NDC:81131-001-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2021
    3NDC:81131-001-0335 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2021
    4NDC:81131-001-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/17/2021
    Labeler - Hubei Flex Daily Chemicals CO., LTD (554533593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hubei Flex Daily Chemicals CO., LTD554533593manufacture(81131-001)
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