Sheffield Triple Antibiotic Ointment
FDA Label NDC 11527-162

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 (NDC 11527-162). 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

→ Active Ingredients (in Each Gram)

→ Purpose

→ Uses

→ Warnings

→ Allergy Alert:

→ Do Not Use

→ Consult A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Consult A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredient

→ Package Label.principal Display Panel

Other

Drug Facts

Active Ingredients (In Each Gram)

Bacitracin 400

Neomycin 3.5 mg

Polymyxin B 5,000 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in minor:

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