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Dr. Sheffield Hemorrhoid

Medically reviewed on October 23, 2017

Dosage form: ointment
Ingredients: ZINC OXIDE 125mg in 1g, PRAMOXINE HYDROCHLORIDE 10mg in 1g
Labeler: Sheffield Pharmaceuticals, LLC
NDC Code: 11527-056

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 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 - 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)

DR. SHEFFIELD HEMORRHOID 
zinc oxide and pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-056
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE125 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
GLYCERYL MONOSTEARATE 
MINERAL OIL 
HIGH DENSITY POLYETHYLENE 
SHARK LIVER OIL 
TALC 
Packaging
#Item CodePackage Description
1NDC:11527-056-501 TUBE in 1 CARTON
121 g in 1 TUBE
2NDC:11527-056-411 TUBE in 1 CARTON
256 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/21/2012
Labeler -  Sheffield Pharmaceuticals, LLC (151177797)
Establishment
NameAddressID/FEIOperations
Sheffield Pharmaceuticals, LLC151177797MANUFACTURE(11527-056)

 
Sheffield Pharmaceuticals, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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