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 May 19, 2020

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  • Active Ingredients

    Ethyl Alcohol 75% Purpose: Antibactirial

  • Purpose

    Antibacterial

  • Uses

    for handwashing to decrease bacteria on the skin

  • Warnings

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

  • DO NOT USE

    do not use in eyes.In case of contact with eye rinse with water

  • WHEN USING

    when using this product do not use in eyes.In case of contact with eye rinse with water

  • Stop use and ask a doctor if

    irritation or redness develop and persist

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help promiptly

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping

  • Other information

    Store under 105℉

  • Inactive ingredients

    ALOE BARBADENSIS LEAF,carbomer,dimethicone,triisopropanolamine,water

  • Package Label - Principal Display Panel

    50mL NDC: 78048-001-01 label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78048-001
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78048-001-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - Dongguan City Dexu Toys Co.,Ltd (403382659)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongguan City Dexu Toys Co.,Ltd403382659manufacture(78048-001)
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