First Aid Macimum Sterngth Bacitraycin Plus
FDA Label NDC 75983-495

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by First Aid Research Corp for the product First Aid Macimum Sterngth Bacitraycin Plus (NDC 75983-495). 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, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, indications & usage, 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 (each gram contains)                                                      Purpose

Bacitracin 500 units........................................................................First Aid Antibiotic

Lidocaine 40 mg....................................................................................Pain Reliever

Otc - Purpose

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.

Indications & Usage

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. and Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

aloe vera gel, mineral oil and petrolatum

Dosage & Administration

Distributed By:

First Aid Research Corp.

3375 Park Ave. Suite 2003

Wantagh, NY 11793 U.S.A.

Made in Korea

Package Label.Principal Display Panel

Image Description (49555.1)

Image Description (49555.1)

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