Label: INSTANT HAND SANITIZER WITH SHEA BUTTER BEADS- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 4, 2010

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  • ACTIVE INGREDIENT

    Medicinal Ingredient                                                    Purpose
    Ethyl Alcohol 62%........................................Antiseptic

  • PURPOSE

    Features

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



  • WARNINGS

    Warning

    For external use only-hands.
    May discolor some fabrics.
    Harmful to wood finishes and plastics.
  • STORAGE AND HANDLING

    Flammable, Keep away from heat and flame.
    Do not store above 105 degree Fahrenheit.
  • STOP USE

    Discontinue if skin becomes irritated and ask a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • INACTIVE INGREDIENT

    Non Medicinal

    Water, Benzophenone-4, Shea Butter - Butyrospermum Parkii, Carbomer, Hydroxyethylcellulose, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Iron Oxides, Isopropyl Myristate, Mannitol, Propylene Glycol, Tocopheryl Acetate.

  • DOSAGE & ADMINISTRATION

    Directions

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

  • WHEN USING

    Keep out of eyes.  In case of contact with eyes, flush thoroughly with water.
    Do not inhale or ingest.
    Avoid contact with broken skin.

  • DESCRIPTION

    This product was not tested on animals.

    Made in China   Item : ML 308

    87271100308

    Use under Lic. and Dist. By:
    LANTERN ENTERPRISES LTD.
    Bellingham, WA 98225

    ? 1-888-273-7955

    Web: LanternBeauty.com

  • PRINCIPAL DISPLAY PANEL

    MELLOW

    INSTANT Hand Sanitizer

    With Shea Butter Beads

    Kills 99.99% of Germs

    2 fl.oz/59 mL


  • PRINCIPAL DISPLAY PANEL

    SheaButter

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER WITH SHEA BUTTER BEADS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50154-4000
    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)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MANNITOL (UNII: 3OWL53L36A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50154-4000-259 mL in 1 BOTTLE
    2NDC:50154-4000-8236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/27/2010
    Labeler - Lantern Enterprises Ltd (240084249)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lantern Science Shenzhen Co. Ltd421252423manufacture
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