Label: DR.PHI ADVANCED 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 February 28, 2016

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  • active ingredient

    ethyl alcohol % 70 V/V

  • purpose

    antimicrobial 

  • uses

    hand sanitizer to help reduce bacteria on the skin that could cause disease

  • INDICATIONS & USAGE

    hand sanitizer to help reduce bacteria on the skin that could cause disease

  • warning

    flamable , keep away from fire or flame

    for external use only

  • keep out of reach of children

    if swallowed get medical help or contact a poison control centre right away

  • when using this product

    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 and rash appears and lasts

  • directions

    place enough prduct on your palm to thoroughly cover your hands

    rub hands together until dry

  • other information

    store below 110​°​ ​​F

    may discolor certian fabrics or surfaces

  • inactive ingredients

    water , glycerin , carbomer , PEG-40 hydrogentated castor oil , aminomethyl propanol, fragrance , EDTA disodium, BHT, tocopheryl acetate , aloe barbadensis (aloe vera) leaf extract.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DR.PHI ADVANCED HAND SANITIZER 
    dr.phi advanced hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58161-156
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    May containEXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    May containFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    May containFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58161-156-0110 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2016
    Labeler - MAMIBA (558528988)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAMIBA558528988manufacture(58161-156)
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