Label: INSTANT HAND SANITIZER- 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 November 26, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient
    75% Ethyl Alcohol
  • PURPOSE

    Purpose
    Antiseptic
  • INDICATIONS & USAGE

    Uses:

    • For hand washing to decrease bacteria/microorganisms on the skin that can cause diseases.
    • Recommended for repeated use.
  • WARNINGS

    Warnings:   
    ◊ For external use only. Avoid contact with broken skin.                                                                                                                                   
    ◊ Flammable, keep away from heat, flame or fire.                                                                                                                                                                                                                                               ◊ Do not use this product,in or near the eyes.
    ◊ If eye contact, immediately rinse thoroughly with a lot of water.
  • STOP USE

    • Stop use and ask a doctor if irritation, redness, or rash develops and persists for more than 3 days.
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Do not inhale or ingest.

  • DOSAGE & ADMINISTRATION

    Directions:
    ◊ Wet hands thoroughly with product                                                                                                                                                                         ◊ Rub hands together covering all surfaces until dry quickly without wiping                                                                                                             ◊ Not recommended for infants                                                                                                                                                                                   ◊ Use in children under 6 years of age must be supervised                                                                                                                                  Other Information:
    ◊ Do not store above 105 F or 39 C
    ◊ May discolor some fabrics, wood finishes and plastics

  • INACTIVE INGREDIENT

    Inactive Ingredients: 
    Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Hamamelis Virginiana (witchhazel) Leaf Extract, Fragrance
  • PRINCIPAL DISPLAY PANEL

    image of bottle label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER  
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69410-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69410-0001-8240 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/26/2014
    Labeler - PrimeCare + Inc. (038816798)
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