Label: D HAND- 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 4, 2020

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  • ACTIVE INGREDIENT

    Active ingredient Ethyl Alcohol 70% v/v

  • PURPOSE

    Purpose Antmicrobial

  • INDICATIONS AND USAGE

    Use[s]

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

    Directions

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

  • DOSAGE AND ADMINISTRATION

    Directions

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

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

  • WARNINGS AND PRECAUTIONS

    Store below 110°F (43°C)

    Children under 6 years of age should be supervised when using.

  • WARNINGS

    Warnings

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

  • 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 a Poison Control Center right away.

  • INACTIVE INGREDIENTS

    Water (Aqua), Glycerin, Carbomer, Triethanolamine

  • PACKAGE LABELS

    LABEL 60 mLLABEL 125 mLLABEL 250 mLLABEL 500 mLLABEL 1000 mL

  • INGREDIENTS AND APPEARANCE
    D HAND 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79050-0030
    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) 0.003 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.293 mL  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.003 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79050-0030-160 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
    2NDC:79050-0030-2125 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
    3NDC:79050-0030-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
    4NDC:79050-0030-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
    5NDC:79050-0030-51000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/04/2020
    Labeler - SODI PINTURAS, S.A. DE C.V. (951579471)
    Registrant - SODI PINTURAS, S.A. DE C.V. (951579471)
    Establishment
    NameAddressID/FEIBusiness Operations
    SODI PINTURAS, S.A. DE C.V.951579471manufacture(79050-0030)
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