Label: MELLOW INSTANT HAND SANITIZER ORIGINAL- 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 December 30, 2009

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  • ACTIVE INGREDIENT

    Medicinal Ingredient
    Ethyl Alcohol 62 percent

  • PURPOSE

    Purpose
    Antiseptic
  • INACTIVE INGREDIENT

    Non Medicinal
    Water (Aqua), Glycerin, Isopropyl Myristate, Propylene Glycol,
    Tocopheryl Acetate, Aminomethyl Propanol, Carbomer,
    Parfum

  • INDICATIONS & USAGE

    Features
    - To decrease bacteria on the skin that could cause disease.
    - Recommended for repeated use.
    - Use anywhere without water.

  • DOSAGE & ADMINISTRATION

    Directions
    - Wet hands thoroughly with product and rub dry without wiping.
    - For children under 6, use only under adult supervision.
    - Not recommended for infants.

  • WARNINGS

    Warning
    - For external use only - hands.
    - Flammable. Keep away from heat and flame.
    - Discontinue if skin becomes irritated and ask a doctor.
    - Keep out of reach of children. In case of accidental ingestion, seek
      professional assistance or contact a Poison Control Center immediately.

  • WHEN USING

    When using this product
    - Keep out of eyes. In case of contact with eyes,
      flush thoroughly with water.
    - Do not inhale or ingest.
    - Avoid contact with broken skin.
  • STORAGE AND HANDLING

    Other Information
    - Do not store above 105 degrees F.
    - May disscolor some fabrics.
    - Harmful to wood finishes and plastics.

  • QUESTIONS

    This product was not tested on animals.

    Made in China

    Used under Lic. and Dist. By:
    LANTERN ENTERPRISES LTD.
    Bellingham, WA 98225
    ? 1-888-273-7955
    Web: LanternBeauty.com

  • PRINCIPAL DISPLAY PANEL

    Lantern Enterprises Hand Sanitizer Original 2 oz 50154-0040-6

  • PRINCIPAL DISPLAY PANEL

    Lantern Enterprises Hand Sanitizer Original 8 oz 50154-0030-5

  • INGREDIENTS AND APPEARANCE
    MELLOW INSTANT HAND SANITIZER ORIGINAL  
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50154-0040
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    2-AMINO-2-METHYL-1-PROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50154-0040-659 mL in 1 BOTTLE
    2NDC:50154-0040-7236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33312/30/2009
    Labeler - Lantern Enterprises Ltd. (240084249)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lantern Science Shenzhen Co. Ltd421222423manufacture
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