Label: WALGREENS- ethyl alcohol gel

  • NDC Code(s): 0363-0859-02, 0363-0859-08
  • Packager: Walgreens
  • 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 February 21, 2023

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70%

  • PURPOSE

    • Leaves hands soft
    • Contains moisturizers
    • Kills 99.9% of common germs.
  • WARNINGS

    For external use only.

    • Flammable
    • keep away from source of heat or fire

    Do not use

    • on infants less than 2 months of age
    • on open skin wounds
    • on broken or damaged skin.

    When using this product avoid

    • contact with yese,
    • If contact occurs, rinse eyes thorughly with water.
    • Do not inhale.

    Stop use and ask a doctor if irritation or redness develops and lasts.

    Incase of accidental ingestion, get medical help or contact a Poison Control Centre immediately.

  • DOSAGE & ADMINISTRATION

    • For occasional and personal use.
    • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
    • Children under 6 years should be supervised when using this product.
  • INDICATIONS & USAGE

    Uses for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

  • STORAGE AND HANDLING

    • Store at a temperature below 110⁰F ( 43⁰C)
    • Avoid freezing and excessive heat above 104⁰F (40⁰C)
  • INACTIVE INGREDIENT

    Water, PEG-6, AMP-Acrylates/Vinyl Isodecanate Crossploymer, Fragrance (parfum), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Yellow 5 (Cl 19140), Blue 1 (Cl 42090)

  • PRINCIPAL DISPLAY PANEL

    2 Fl oz8 Fl oz

  • INGREDIENTS AND APPEARANCE
    WALGREENS 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0859
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-6 ISOSTEARATE (UNII: 0E2639OTJY)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BASIC BLUE 1 (UNII: 92N74OA24D)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0859-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2023
    2NDC:0363-0859-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/15/2023
    Labeler - Walgreens (008965063)
    Registrant - Apollo Health and Beauty Care Inc (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc201901209manufacture(0363-0859)
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