Label: HAND SANITIZING WIPES- alcohol cloth

  • 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 May 3, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                                 Purpose

    Ethyl Alcohol 62%                               Sanitizer

  • DESCRIPTION

    Uses:

    To decrease bacteria on the skin that could cause diseases

    Recommended for repeated use

  • WARNINGS

    Warnings:

    For external use only-hands. Use only as directed.  Excessive use or prolonged exposure may cause irritation to skin. Discontinue use if rash, redness, or itching occurs.

    Flammable. Keep away from heat and flame.

  • WHEN USING

        When using this product

    • Keep out of eyes. In case of contacting with eyes, immediately flash with water and call a doctor.
    • Avoid contacting with a broken skin.
  • STOP USE

    Stop using and ask a doctor if irritation or redness develops.

  • 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.


  • INDICATIONS & USAGE

    Directions

    Adults and children two years and over:

    • Apply to hands
    • Allow skin to dry without wiping
  • STORAGE AND HANDLING

            Other Information

    • Do not store in temperatures over 118F
    • Children under six years of age should be supervise while using this product.
    • May discolor certain fabrics.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, glycerin, carbomer, triethanolamine, aloe barbadensis extract, and vitamin E

  • PRINCIPAL DISPLAY PANEL

    labeLabel on the inner package

  • PRINCIPAL DISPLAY PANEL

    outerlabel on outer package

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25225-016(NDC:None)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R) 36.955 
    Glycerin (UNII: PDC6A3C0OX) 1 
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.005 
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.02 
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.005 
    TROLAMINE (UNII: 9O3K93S3TK) 0.015 
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25225-016-011 in 1 POUCH
    2NDC:25225-016-022 in 1 POUCH
    3NDC:25225-016-0310 in 1 POUCH
    4NDC:25225-016-0420 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33305/03/2010
    Labeler - Unique Holding Group Inc (529047265)
    Registrant - Unique Holding Group Inc (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Holding Group Inc529047265manufacture
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