Label: HANDEX INSTANT HAND SANITIZER- 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 March 2, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients                                                              Purpose

    Ethyl Alcohol 62 percent..................................................Antimicrobial


  • PURPOSE

    Uses

    For Hand washing to decrease bacteria on the skin that may cause disease.

    Recommended for repeat use.

    6 hour protection: Hands will be protected from germs for over 6 hours as long

    as hands are not washed with soap and water during that period of time.

  • WARNINGS

    Warning Directions

    For external use only. Flammable, keep away from heat and flame. When using this product keep out of eyes.

    In case of contact with eyes, flush throughly with water. Stop use and ask a doctor if irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

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

    For children under 6, use only under adult supervision.


  • STORAGE AND HANDLING

    Other Information

    Do not store above 105 F.

    May discolor some fabrics.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (Aqua), PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Fragrance (Parfum), Denatonium Benzoatem CI19140 (YELLOW 5).


  • DESCRIPTION


    Made in China

    Dist. By E and T Inc.   Monrovia, Ca     handex.net
  • PRINCIPAL DISPLAY PANEL

    New!

    Tear


    6 Hour Protection

    Handex

    "Protection Through Germ Prevention"

    Instant Hand Sanitizer

    Kills 99.99 percent of germs

    Net Wt .05oz (1.42g)
  • PRINCIPAL DISPLAY PANEL

    handex142

  • INGREDIENTS AND APPEARANCE
    HANDEX INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50756-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50756-100-051.42 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33302/26/2010
    Labeler - E T Inc. (603568270)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Nature Caring Products Co., Ltd529296751manufacture
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