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 June 2, 2020

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  • DOSAGE

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

  • INACTIVE INGREDIENTS

    Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

  • DIRECTIONS

    Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

  • 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.

  • PURPOSE

    PURPOSE ANTIMICROBIAL

  • WARNINGS

    Warnings

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

  • ACTIVE INGREDIENT

    Active ingredient. Ethyl Alcohol 70% v/v

  • STOP USE ASK A DOCTOR

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

  • PRINCIPAL DISPLAY

    LABEL 125 ml FINALLABEL 250 mlLABLE 1000 mLLABEL 500 mL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78525-2000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 mL  in 1 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.2585 mL  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78525-2000-2125 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    2NDC:78525-2000-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    3NDC:78525-2000-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    4NDC:78525-2000-51000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2020
    Labeler - REALITY PHARMA, S.A. DE C.V. (951578646)
    Registrant - REALITY PHARMA, S.A. DE C.V. (951578646)
    Establishment
    NameAddressID/FEIBusiness Operations
    REALITY PHARMA, S.A. DE C.V.951578646manufacture(78525-2000)
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