Label: HAND SANITIZER- 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 April 13, 2020

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  • Active Ingredient

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help decrease bacteria on the skin. For use when soap and water are not available.

  • Do not use

    ■ In children less than 2 months of age

    ■ on open skin wounds

  • Warnings

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

  • When using this product

    Keep out of eyes ears an mouth . In case of eye contact immediately flush eyes throughly with water

  • 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

    In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

  • Directions

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

  • Other information

    ■ Store between 15º-30ºC (59º-89ºF) ■ Avoid freezing and excessive heat above 40ºC (140ºF) ■ May discolor fabrics or surfaces

  • Inactive Ingredients

    carbomer, glycerin, triethanolamine, water

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60604-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60604-010-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/06/2020
    2NDC:60604-010-37110 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/06/2020
    Labeler - reBom Co., Ltd. (688733595)
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