Label: FIRST AID ONLY INSTANT 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 June 9, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% w/w

  • Purpose

    Antimicrobial

  • Use

    .hand sanitizer to help reduce microbes on the skin

  • Warnings

    Flammable. Keep away from fire or flame For external use only

  • WHEN USING

    When using this product, do not use in or near the eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    put enough gel in your palm to cover your hands and rub hand together rapidly until dry

    ■ children under 6 years of age should be supervised when using this product

  • Other information

    ■ store below 110°F {43°C)

    ■ may discolor certain fabrics or surfaces

  • Inactive ingredients

    carbomer, fragrance, glycerin, propylene glycol, silicone, triethanolamine, water (aqua)

  • Package Label - Principal Display Panel

    Bottle Label60 mL NDC: 0924-0401-01

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0401(NDC:28691-0700)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICON (UNII: Z4152N8IUI)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0401-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/2020
    2NDC:0924-0401-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/2020
    3NDC:0924-0401-03200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/2020
    4NDC:0924-0401-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/2020
    5NDC:0924-0401-05750 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/2020
    6NDC:0924-0401-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/09/2020
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0401) , repack(0924-0401)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0401) , repack(0924-0401)
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