Label: ETHYL 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 2, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses • Hand sanitizer to help reduce bacteria on the skin.

  • Warnings:

    Flammable. Keep away from fire or flame.

    For external use only.

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

    Stop use and ask doctor if redness or irritation develops & persists for more than 72 hours.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

  • DOSAGE & ADMINISTRATION

    Directions: Wet hands thoroughly with product and allow to dry. Children under 6 years should be supervised when using this product.

  • STORAGE AND HANDLING

    Other Information: Store below 110°F (43°C). May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENT

    Inactive ingredients: Aqua, Isopropyl Alcohol, Polysorbate 20, Carbomer, Triethanolamine, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Parfum, Lilial, Benzyl Salicylate, Linalool, Hexyl Cinnamal, Alpha-Isomethyl Ionone.

  • SPL UNCLASSIFIED SECTION

    WHEN EVERY SECONDS COUNTS

    Kills 99% of germs!

    ResQue1st, LLC

    www.resque1st.com

    Clearwater, FL 33755

    Made in USA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ETHYL ALCOHOL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73762-070
    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
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73762-070-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/23/2020
    Labeler - RESQUE1ST LLC (117435023)
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