Bacitracin: Package Insert and Label Information

BACITRACIN- bacitracin ointment
Blossom Pharmaceuticals

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 ingredient Purpose
Bacitracin Zinc (Equal to 500 Bacitracin Units) First Aid Antibiotic

Purpose:

First aid to help prevent infection.

Warnings:

For external use only

Dosage and Administration

Directions:

  • clean the affected areas
  • apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily.
  • may be covered with a sterile bandage

Indications and Usage

First aid to help prevent infection in:

  • minor cuts
  • scrapes
  • burns

Stop Use and ask a doctor if:

  • the condition persists or gets worse, or if a rash or other allergic reaction develops.

Do Not Use if:

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

Ask a doctor before use:

  • in case of deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away

Other information

  • store at controlled room temperature 15°-30° C (59°-86° F)

Inactive ingredients

Light Mineral Oil, White Petrolatum

Principal Display Panel

Bacitracin Ointment

BP Bacitracin.jpg

Bacitracin
(click image for full-size original)
BACITRACIN
bacitracin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61767-219
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 500 [iU] in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61767-219-01 28.35 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 03/06/2014
Labeler — Blossom Pharmaceuticals (677381470)
Establishment
Name Address ID/FEI Operations
Blossom Pharmaceuticals 677381470 manufacture (61767-219)

Revised: 03/2014 Blossom Pharmaceuticals

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