First Aid Macimum Sterngth Bacitraycin Plus: Package Insert and Label Information

FIRST AID MACIMUM STERNGTH BACITRAYCIN PLUS — bacitracin and lidocaine ointment
First Aid Research Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients (each gram contains) Purpose

Bacitracin 500 units………………………………………………………………First Aid Antibiotic

Lidocaine 40 mg…………………………………………………………………………Pain Reliever

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings For external use only.

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

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

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a 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

  • 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

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 ingredients

aloe vera gel, mineral oil and petrolatum

Distributed By:

First Aid Research Corp.

3375 Park Ave. Suite 2003

Wantagh, NY 11793 U.S.A.

Made in Korea

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FIRST AID MACIMUM STERNGTH BACITRAYCIN PLUS
bacitracin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75983-495
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g
LIDOCAINE (LIDOCAINE) LIDOCAINE 40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75983-495-55 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (75983-495-55)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 06/30/2013
Labeler — First Aid Research Corp (089405927)

Revised: 05/2017 First Aid Research Corp

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