DR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]

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  • DR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]

DR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]
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NDC 11527-056-41, 11527-056-50
Set ID c07619fe-8383-4bd6-b087-5d6c7b847466
Category HUMAN OTC DRUG LABEL
Packager Sheffield Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number PART346
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Pramoxine HCL1%

    Zinc Oxide 12.5%

  • Purpose

    Local anesthetic

    Protectant

  • Uses

    • for the temporary relief of local and anorectal itching, burning and discomfort associated with hemorrhoids, and anorectal disorders, inflamed hemorrhoidal tissues or piles.
  • Warnings

    • If condition worsens or does not improve within 7 days, consult a doctor.
    • Do not exceed the recommended daily dosage unless directed by a doctor.
    • In case of bleeding, consult a doctor promptly.

    • Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.
    • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults: When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    • Children under 12 years of age: consult a doctor.
    • Remove cap from tube and puncture seal with opposite end of cap.
    • For external use; cover the entire affected area with a thin layer up to 5 times daily.
    • FOR INTRARECTAL USE: Attach applicator to tube. Lubricate applicator well, then gently insert into rectum. Squeeze tube to deliver medication.
  • Other information

    • Store at room temperature 20-25°C (68-77°F).
    • Close cap tightly after use.
    • Applicator included in carton.
  • Inactive ingredients

    Dicalcium Phosphate. Glyceryl Stearate, Mineral Oil, Polyethylene Wax, Shark Liver Oil, Talc

  • Questions?

    1-800-222-1087

  • Principal Display Panel - Carton Label

    Dr. Sheffield's

    NDC 11527-056-50

    Hemorrhoid Ointment

    Pramoxine HCL 1% Anesthetic

    Helps relieve the local itching and discomfort associated with hemorrhoids

    NET WT. 0.75 oz. (21g)

    Principal Display Panel - Carton Label
  • Principal Display Panel - Tube Label

    Dr. Sheffield's

    NDC 11527-056-50

    Hemorrhoid Ointment

    Pramoxine HCL 1% Anesthetic

    Helps relieve the local
    itching and discomfort
    associated with hemorrhoids

    NET WT. 0.75 oz. (21g)

    Principal Display Panel - Tube Label
  • INGREDIENTS AND APPEARANCE
    DR. SHEFFIELD HEMORRHOID 
    zinc oxide and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-056
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE125 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SHARK LIVER OIL (UNII: 4B24275HEU)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-056-501 in 1 CARTON12/21/201204/30/2017
    121 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11527-056-411 in 1 CARTON12/21/201204/30/2017
    256 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/21/2012
    Labeler -  Sheffield Pharmaceuticals, LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals, LLC151177797MANUFACTURE(11527-056)
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