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 August 6, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v.

    Purpose

    Antiseptic

  • Use

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

  • Warnings

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

    Do not use

    • on children less than 2 months of age
    • on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 59ºF-86ºF (15ºC-30ºC)
    • Avoid freezing and excessive heat above 104ºF (40ºC)
  • Inactive ingredients

    Carbomer, Glycerin, Purified water, Trolamine

  • Package Label - Principal Display Panel

    3780 mL NDC: 78361-003-01

    3780ml label
    1000 mL NDC: 78361-003-02
    1000ml front label 1000ml back label
    500 mL NDC: 78361-003-03
    500ml front label 500ml back label
    250 mL NDC: 78361-003-04
    250ml front label 250ml back label
    330 mL NDC: 78361-003-05
    330ml front label 330ml back label
    60 mL NDC: 78361-003-06
    60ml label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78361-003
    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
    TROLAMINE (UNII: 9O3K93S3TK) 0.1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.4 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78361-003-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    2NDC:78361-003-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    3NDC:78361-003-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    4NDC:78361-003-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    5NDC:78361-003-05330 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    6NDC:78361-003-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - Diquisa, S.A. De C.V. (815736509)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diquisa, S.A. De C.V.815736509manufacture(78361-003)
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