Label: INSTANT HAND ANTISEPTIC- ethyl 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 October 18, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient:
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose Antiseptic

  • WARNINGS

    Warnings: Flammable. Keep away from fire or flame.

    For external use only.

    Avoid contact with broken skin.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help.

  • DOSAGE & ADMINISTRATION

    Directions:

    Not recommended for infants.

    Wet hands thoroughly with product and allow to dry without wiping.

    Children under 6 years of age must be supervised when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Glycerin, Propylene glycol, Carbomer, Triethanolamine,Aloe Barbadensis Leaf Juice,

  • STORAGE AND HANDLING

    Other Information:

    Do not store above 110 F. May discolor some fabrics.

  • INDICATIONS & USAGE

    Uses: For hand washing to decrease bacteria on the skin. Recommended for repeated use.

  • WHEN USING

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

    NORTHSIDE HOSPITAL

    Instant Hand Antiseptic
    62% w/w Ethyl Alcohol

    Creating a Healing Environment

    We provide our patients with the essentials
    they need to stay well rested.
    This is an important part of healing,
    both here and at home.

    1.9 FL OZ / 53 mL

    Distributed by:
    ASP Global, LLC
    7800 Third Flag Parkway,
    Austell, GA 30168, USA

    Rev 03-2021

    PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND ANTISEPTIC 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-001-0253 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/18/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/18/2015
    Labeler - ASP Global, LLc (080361159)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!