First Aid Antibiotic Bacitraycin Plus Maximum Strength
FDA Label NDC 47046-163

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Anicare Pharmaceuticals Pvt. Ltd for the product First Aid Antibiotic Bacitraycin Plus Maximum Strength (NDC 47046-163). 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 ingredient (each gram contains)                                                                        

Bacitracin             500 units

Pramoxine HCl     10 mg

Otc - Purpose

Purpose

First Aid Antibiotic

Pain Reliever

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

Otc - Ask Doctor

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

Otc - Stop Use

Stop use and ask a doctor if

  • the condition persists or gets worse
  • 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
  • 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

Storage And Handling

Other information

  • store at 15° to 25° C (59° to 77° F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

aloe vera leaf,  methylparaben, mineral oil, petrolatum, propylparaben, stearyl alcohol

Other

Distributed by:

First Aid Research Corp.

Jupiter, FL 33478

Made in India

Package Label.Principal Display Panel

Image Description (Bacitraycin Plus)

Image Description (Bacitraycin Plus)

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