Label: GEL 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 September 12, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    To help reduce bacteria on skin.

  • Warnings

    For external use only. Flammable, keep away from source of heat & fire.

  • WHEN USING

    When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use & ask doctor if irritation occurs or redness develops & persists.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.

  • Directions

    Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.

  • Inactive ingredients

    Water (Aqua, Eau), Glycerin, Liquid Preneutralized Thickener/Emulsifier, Squalane, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

  • Package Label - Principal Display Panel

    5 Peaks 3.4oz Tube5 Peaks 8.45 oz Bottle5 Peaks 16.9 oz Bottle5 Peaks 1 Liter Bottle5 Peaks 1 Gallon Bottle5 Peaks 55 Gallon Drum5 Peaks 1000 L IBC Tote

    100 mL NDC: 80242-100-01

    250 mL NDC: 80242-100-02

    500 mL NDC: 80242-100-03

    1 L NDC: 80242-100-04

    3.785 L NDC: 80242-100-05

    208 L NDC: 80242-100-06

    1000 L NDC: 80242-100-07

    iUnderstand Product Label

    iUnderstand 8.45 oz bottleiUnderstand 16.9 oz bottleiUnderstand 1 Liter Bottle

    250 mL NDC: 80242-100-02

    500 mL NDC: 80242-100-03

    1 L NDC: 80242-100-04

  • INGREDIENTS AND APPEARANCE
    GEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80242-100
    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
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SQUALANE (UNII: GW89575KF9)  
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80242-100-01100 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2020
    2NDC:80242-100-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    3NDC:80242-100-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    4NDC:80242-100-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    5NDC:80242-100-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    6NDC:80242-100-06208000 mL in 1 DRUM; Type 0: Not a Combination Product09/01/2020
    7NDC:80242-100-071000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2020
    Labeler - 5 Peaks Products, LLC (117631506)
    Registrant - 5 Peaks Products, LLC (117631506)
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