Label: GEL 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 January 13, 2022

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • 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

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

    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.

  • 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.

  • 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 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water, Glycerin, Polyquaterniun-37, hydrogen peroxide. Fragrance

  • Package Label - Principal Display Panel

    250 mL NDC: 74793-0005-1

    500 mL NDC: 74793-0005-2 500 mL label NDC 74793-0005-23780 mL NDC: 74793-0005-3 3780 mL label NDC 74793-0005-3250 mL label NDC 74793-0005-1

  • PRINCIPAL DISPLAY PANEL

    500 mL NDC # 74793-0005-2

  • INGREDIENTS AND APPEARANCE
    GEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74793-0005
    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
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW) 0.04 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN) 0.67 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74793-0005-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    2NDC:74793-0005-2500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    3NDC:74793-0005-33780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/06/2020
    Labeler - 74793 (117054225)
    Registrant - Streamline Polymers LLC (117054225)
    Establishment
    NameAddressID/FEIBusiness Operations
    Streamline Polymers LLC117054225manufacture(74793-0005)
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