DR.PHI ADVANCED HAND SANITIZER GEL [MAMIBA]

DR.PHI ADVANCED HAND SANITIZER GEL [MAMIBA]
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NDC 58161-156-02, 58161-156-03, 58161-156-04
Set ID 043c2fe6-7d57-4d3b-91ee-1f8145eec04f
Category HUMAN OTC DRUG LABEL
Packager MAMIBA
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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:58161-156-0250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2016
    2NDC:58161-156-03315 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2016
    3NDC:58161-156-0415 mL in 1 POUCH; 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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