Triple Antibiotic First Aid Antibiotic Ointment
FDA Label NDC 83650-112

12 label sections · Submitted to the FDA by Savvy Care & Cosmetics Pvt. Ltd. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Savvy Care & Cosmetics Pvt. Ltd. for the product Triple Antibiotic First Aid Antibiotic (NDC 83650-112). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - 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

Otc - Active Ingredient

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U

Otc - Purpose

Purpose

First Aid Antibiotic

Indications & Usage

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • in the eyes
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
  • over large areas of the body

Otc - Ask Doctor

Ask a doctor before use on

  • on deep puncture wounds, animal bites, or serious burns

Otc - Stop Use

Stop use and consult a doctorif the condition persists or gets worse, or if a rash or other allergic reaction develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • Clean the affected area and dry thoroughly
  • May be covered with a sterile bandage
  • 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

Other

Other Information

  • Store at 20°C to 25°C (68°F to 77°C)
  • Lot No. & Exp. Date: see crimp of tube

Inactive Ingredient

Inactive Ingredients

cocoa butter, cotton seed oil, olive oil,  sodium pyruvate, vitamin E, white petrolatum, hard parrafin, mineral oil

* Please review the disclaimer below.