Label: 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 September 21, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 73% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • Warnings

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

  • Do not use

    • on open skin wounds
    • do not inhale or ingest
    • do not use on infants
  • WHEN USING

    When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water

    ■Avoid contact with open skin ■ Do not inhale or ingest

  • STOP USE

    Stop use and ask a doctor if skin irritation or redness develops.

  • 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

    Wet hands thoroughly with product and allow to dry without wiping
    Children under 6 years of age use only under adult supervision
    Not recommended for infants

  • Other information

    • Store below 110F (43C)
    • May discolor fabrics/surfaces
  • Inactive ingredients

    Aminomethyl Propanol, Ethylmethacrylate, Purified USP Water, Fragrance

  • 330 gallon

    330 gallon

  • 55 gallon

    55 gallon

  • 1 gallon

    1 gallon

  • 32 oz

    32 oz

  • 16 oz

    16 oz

  • 8 oz

    8 oz

  • 4 oz

    4 oz

  • 2 oz

    2 oz

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79117-073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL METHACRYLATE (UNII: 80F70CLT4O)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79117-073-013785 mL in 1 JUG; Type 0: Not a Combination Product09/18/2020
    2NDC:79117-073-55208198 mL in 1 DRUM; Type 0: Not a Combination Product09/18/2020
    3NDC:79117-073-991249190 mL in 1 DRUM; Type 0: Not a Combination Product09/18/2020
    4NDC:79117-073-32947 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/18/2020
    5NDC:79117-073-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/18/2020
    6NDC:79117-073-08237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/18/2020
    7NDC:79117-073-04118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/18/2020
    8NDC:79117-073-0259 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2020
    Labeler - Emerge Technologies, Inc. (143443492)
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