Sheffield Triple Antibiotic Plus Pain Relief Ointment
FDA Label NDC 11527-161

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sheffield Pharmaceuticals Llc for the product Sheffield Triple Antibiotic Plus Pain Relief (NDC 11527-161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each gram), purpose, uses, warnings, allergy alert:, do not use, consult a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients (In Each Gram)

Bacitracin 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine hydrochloride 10mg

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

Uses

helps prevent infection in and temporarily relieves pain due to:

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Allergy Alert:

  • do not use if you are allergic to any of the ingredients

Do Not Use

  • in or near the eyes
  • on large areas of the body

Consult A Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product

  • do not use longer than 1 week

Stop Use And Consult A Doctor If

  • condition persists or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a rash or other allergic reaction develops

Otc - Keep Out Of Reach Of Children

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

Directions

  • clean the affected area
  • apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
  • may be covered with a sterile bandage

Other Information

  • Store at a controlled room temperature 68°-77°F (20°-25°C)

Inactive Ingredient

Petrolatum

Package Label.Principal Display Panel


Principal Display Panel – Carton Label

Dr. Sheffield's NDC 11527-161-55

Triple Antibiotic Plus Pain Relief 
Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate •  Pramoxine HCL             
First Aid Antibiotic  Plus Pain Relieving Ointment

NET WT. 1 oz. (28g)


Principal Display Panel – Tube Label

Dr. Sheffield's NDC 11527-161-55

Triple Antibiotic Plus Pain Relief

Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate • Pramoxine HCL    
First Aid Antibiotic/Pain Relieving Ointment

NET WT. 1 oz. (28g)
First Aid Treatment for Minor Cuts, Scrapes and Burns

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