Topcare Triple Antibiotic Ointment
FDA Label NDC 36800-416

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Triple Antibiotic (NDC 36800-416). 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 active ingredients (in each gram), purpose, use, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each Gram)

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Package/label Principal Display Panel

Active Ingredients (In Each Gram)

Bacitracin zinc equivalent to 400 units bacitracin

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 5,000 units as polymyxin B sulfate

Purpose

First aid antibiotic

Use

first aid to help prevent infection in minor:

cuts
scrapes
burns

Warnings

For external use only.

Do Not Use

if you are allergic to any of the ingredients
in the eyes
over large areas of the body

Ask A Doctor Before Use If You Have

deep or puncture wounds
animal bites
serious burns

Stop Use And Ask A Doctor If

you need to use longer than 1 week
condition persists or gets worse
rash or other allergic reaction develops

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

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