NUMPOT TOPICAL ANESTHETIC (LIDOCAINE, PETROLATUM) OINTMENT [UNIT DOSE, LTD.]

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NUMPOT TOPICAL ANESTHETIC (LIDOCAINE, PETROLATUM) OINTMENT [UNIT DOSE, LTD.]
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NDC 67194-018-01
Set ID 9143b50b-7d76-4545-aa2e-1bb77ffb44ae
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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  • DRUG FACTS

  • ACTIVE INGREDIENTS

    Lidocaine 5%

    Petrolatum 71%

    PURPOSE

    Anesthetic

    Skin Protectant

  • USES:

    Temporarily relieves local discomfort, pain and Swelling, or burning associated with anorectal disorders.

  • WARNING:

    External use only. Keep out of eyes. Allergic reactions can occur.

    STOP USE & ASK A DOCTOR:

    If condition worsens or does not improve within 7 days

    • If redness, irritation, pain, swelling or other symptoms develop or increase
    • If bleeding occurs.

    KEEP OUT OF REACH OF CHILDREN:

    If swallowed get medical help or contact a Poison Control Center ASAP.

  • DIRECTIONS:

    Apply sparingly to affected area as often as needed up to 6 times daily.

    ​STORE IN COOL DARK AREA.

  • INACTIVE INGREDIENTS:

    Mineral Oil, Lanolin Alcohol, Polysorbate 60, Paraffin, Sorbitan Oleate, Tocopheryl Acetate (Vit. E Acetate), Aloe Barbadensis (Organic Aloe Vera) leaf juice, Cholecalciferol (Vit. D3), Phytonadione (Vit. K1)

  • Questions?

    Call us at Toll Free (888)664-9990

  • Package Labeling:

    Numpot 1Numpot 2

  • INGREDIENTS AND APPEARANCE
    NUMPOT TOPICAL ANESTHETIC 
    lidocaine, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67194-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM710 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    PHYTONADIONE (UNII: A034SE7857)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67194-018-0128 g in 1 JAR; Type 0: Not a Combination Product01/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/20/2016
    Labeler - Unit Dose, Ltd. (119080393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unit Dose, Ltd.119080393relabel(67194-018)
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