Label: POMEGRANATE ROSE HAND SANITIZER- alcohol liquid

  • 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 November 5, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 62%  

  • PURPOSE


    Purpose:

    Sanitizer
  • INDICATIONS & USAGE


    Uses:

    To decrease the bacteria on the skin that could cause disease. Recommended for repeated use.
  • WARNINGS


    Warnings:

    For external use only-hands.
    Use only as directed.
    Excessive use or prolonged exposure may cause irritation to the skin.
    Discontinue use if irritation, redness, or itching occurs.
    Flammable. Keep away from heat and flame
  • WHEN USING

    When Using This Product:

    Keep out of eyes. In case of contact with eyes, flush immediately with water and call a doctor.

    Avoid contact with broken skin


  • ASK DOCTOR


    Stop Use 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 of contact a Poison Control center immediately
  • DOSAGE & ADMINISTRATION

    Directions:

    Put a thumb size amount in your palm and rub hands together briskly until dry

  • STORAGE AND HANDLING

    Other Information

    Do not store in temperatures over 118F

    Children under six years of age should be supervised while using this product.

    May discolor certain fabrics

  • INACTIVE INGREDIENT



    Inactive Ingredients

    aloe barbadensis gel, carbomer, deionized water, Fragrance, glycerin, propylene glycol, D and C Red No. 33, triethanolamine, and vitamin E

  • PRINCIPAL DISPLAY PANEL

    labelabel

  • INGREDIENTS AND APPEARANCE
    POMEGRANATE ROSE HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25225-019(NDC:None)
    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) 35.5998 g  in 100 g
    Propylene Glycol (UNII: 6DC9Q167V3) 0.5 g  in 100 g
    Glycerin (UNII: PDC6A3C0OX) 1 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 g  in 100 g
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.33 g  in 100 g
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.01 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.35 g  in 100 g
    POMEGRANATE (UNII: 56687D1Z4D) 0.2 g  in 100 g
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25225-019-0128 g in 1 BOTTLE, PLASTIC
    2NDC:25225-019-0259 g in 1 BOTTLE, PLASTIC
    3NDC:25225-019-04237 g in 1 BOTTLE, PLASTIC
    4NDC:25225-019-05500 g in 1 BOTTLE, PLASTIC
    5NDC:25225-019-03222 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/13/2010
    Labeler - Unique Holding Group Inc (529047265)
    Registrant - Unique Holding Group Inc (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Holding Group Inc529047265manufacture
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