Label: DR.PHI INSTANT HAND SANITIZER gel

  • 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 September 2, 2014

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  • Active Ingredient

    Ethyl Alcohol 70% V/V

  • Drug Facts

    label 10 ml

  • Purpose

    Antimicrobial

  • uses

    HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE

  • uses

    HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE

  • Warnings

    Flammable, keep away from fire or flame.

    For external use only

  • WHEN USING

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    if irritation or rash appears and lasts

  • Keep out of reach of children

    If swallowed get medical help or contact a poison control center right away.

  • Directions

    Place enough product in your palm to thoroughly cover your hands Rub hands together until dry Children under 6 years of age should be supervised when using this product

  • other information

    Store below 110°F (43°C)

    May discolor certain fabrics or surfaces

  • inactive ingredients

    Water (aqua), glycerin, Carbomer, Aminmethylpropanol

  • INGREDIENTS AND APPEARANCE
    DR.PHI INSTANT HAND SANITIZER 
    dr.phi instant hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58161-155
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58161-155-0236 in 1 PACKAGE
    1NDC:58161-155-0110 mL in 1 TUBE
    2NDC:58161-155-0350 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2014
    Labeler - MAMIBA (558528988)
    Registrant - MAMIBA (558528988)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAMIBA558528988manufacture(58161-155)
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