Label: 75% ALCOHOL HAND SANITZER- 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, 2020

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  • Active ingredient(s)

    Ethyl Alcohol 75% v/v.............Antimicrobial

  • PURPOSE

    Hand sanitizer, Antimicrobial

  • Uses

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • On children less than 2 months of age
    • On open skin wounds.

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.
    Supervise children under 6 years of age when using product to avoid swallowing.

  • Other information

    • Store below 110°F (43°C)

    • May Discolor certain fabrics.

  • Inactive ingredients

    Deionized Water, Glycerol, Carbomer, Triethanolamine

  • SPL UNCLASSIFIED SECTION

    Accelerate360, LLC, Smyrna, GA 30080

  • PRINCIPAL DISPLAY PANEL

    60ml 74212-1001-1

    LIFETOGO

    HAND

    SANITIZER

    75% ALCOHOL

    2 FL OZ (60 ml)

    PDP

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL HAND SANITZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74212-1001(NDC:56084-022)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74212-1001-160 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/10/2020
    Labeler - Accelerate360 Llc (117415425)
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