NUMSTICK (PETROLATUM, LIDOCAINE) STICK [UNIT DOSE, LTD.]

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NUMSTICK (PETROLATUM, LIDOCAINE) STICK [UNIT DOSE, LTD.]
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NDC 67194-014-01
Set ID 127bbd87-5402-4da2-abf3-dac6367735ec
Category HUMAN OTC DRUG LABEL
Packager Unit Dose, Ltd.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
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  • Active Ingredient in each Gram

    Petrolatum (White) 60%

    Lidocaine 5.0%

    Skin Protectant

    External or Topical Analgesic

  • USES:

    Temporary relief of anorectal discomfort

  • WARNING:

    External Use Only. Keep out of eyes.. You may develop allergic reaction to ingredients.

    Do Not Use:

    More than directed or in the rectum with any mechanical device or applicator.

    STOP USE AND ASK A DOCTOR:

    if pain worsens, or bleeding or swelling occurs

    KEEP OUT OF REACH OF CHILDREN

    and get medical help right away if swallowed.

  • DIRECTIONS:

    Apply .5-1.0 gm. to desired clean dry area up to 4 times/day as needed.

  • INGREDIENTS:

    Simmondisa Chinensis (Jojoba) Seed oil, Lanolin, Beeswax, Ozokerite wax, Candelilla wax, Paraffin, Ethoxydiglycol, Menthol, Tocopheryl Acetate, Cholecalciferol, Retinyl Palmitate, Phytonadione

  • Package Labeling:

    Label 1

  • INGREDIENTS AND APPEARANCE
    NUMSTICK 
    petrolatum, lidocaine stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67194-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM600 mg  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    MENTHOL (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PHYTONADIONE (UNII: A034SE7857)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67194-014-014 g in 1 TUBE; Type 0: Not a Combination Product01/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/22/2016
    Labeler - Unit Dose, Ltd. (119080393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unit Dose, Ltd.119080393relabel(67194-014)
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