Label: FOREVER HAND SANITIZER 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 30, 2010

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  • Active Ingredients


    Active ingredient     Purpose
    Ethyl Alcohol 62%...Antimicrobial




  • Inactive Ingredients

    Water (Aqua), Aloe Barbadensis Leaf Juice (Stabilized* Aloe Vera Gel), Honey, Isopropyl Alcohol, Fragrance (Parfum), Glycerin, Tetrahydroxypropyl, Ethylenediamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Isopropyl Myristate.
  • Purpose Section

    Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    Warnings

    Fore external use only.

    Flammable. Keep away from fire or flame.

  • Indications & Usage

    • do not use in or near the eyes. If contact occurs, rinse throughly with water.
    • avoid contact with broken skin.
  • Stop use and ask a doctor if

    Stop use and ask a doctor if

    • rash or irritation develops and lasts.
  • Keep out of reach of children

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

  • Dosage & Administration Directions

    Directions

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • children under 6 years of age should be supervised when using this product
  • Other information

    • store at 20°C to 25°C (68°F to 77°F) when possible.  Do not store above 40°C (104° F).
    • may discolor certain fabrics
  • Package Label Principal Display Panel

    image of product labelLabel

  • INGREDIENTS AND APPEARANCE
    FOREVER HAND SANITIZER  HAND SANITIZER
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11697-318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol36.58 mL  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Honey (UNII: Y9H1V576FH)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    Cymbopogon Citratus Leaf (UNII: 06JMS448M5)  
    Glycerin (UNII: PDC6A3C0OX)  
    EDETOL (UNII: Q4R969U9FR)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11697-318-0259 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/16/2010
    Labeler - Aloe Vera of America, Inc. (049049463)
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