Triple Antibiotic
FDA Label NDC 53210-1004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Morales Distributors Inc. for the product Triple Antibiotic (NDC 53210-1004). 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), purposes, uses, warnings, ask a doctor before use if you have, when using this product, 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)

→ Purposes

→ Uses

→ Warnings

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Label

Active Ingredients (In Each Gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Purposes

First aid antibiotic

Uses

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

Ask A Doctor Before Use If You Have

serious burns
deep or puncture wounds
animal bites

When Using This Product

do not use in the eyes
do not apply over large areas of the body

Stop Use And Ask A Doctor If

you need to use more than 1 week
condition persists or gets worse
symptoms persist for more than 1 week or clear up and occur again within a few days
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.

Directions

adults and children 2 years of age and older:
- 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
- children under 2 years of age: ask a doctor