DR. SHEFFIELD HEMORRHOID- zinc oxide and pramoxine hydrochloride ointment
Sheffield Pharmaceuticals, LLC

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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11527-056
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	125 mg in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11527-056-50	1 in 1 CARTON	12/21/2012	04/30/2017
1		21 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11527-056-41	1 in 1 CARTON	12/21/2012	04/30/2017
2		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	12/21/2012	04/30/2017

Labeler - Sheffield Pharmaceuticals, LLC (151177797)

Name	Address	ID/FEI	Business Operations
Establishment
Sheffield Pharmaceuticals, LLC		151177797	MANUFACTURE(11527-056)

Revised: 9/2022

Document Id: 919e0fab-4a21-47ee-821a-6b9eeb5677d2

Set id: c07619fe-8383-4bd6-b087-5d6c7b847466

Version: 3

Effective Time: 20220921

Sheffield Pharmaceuticals, LLC