Bacitracin With Zinc: Package Insert and Label Information

BACITRACIN WITH ZINC- bacitracin zinc ointment
Cardinal Health

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

Bacitracin Zinc (500 units in each gram)

Purpose

First Aid Antibiotic

Uses

first aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For external use only

Do not use

  • in the eyes or apply 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 if you have

deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 room temperature

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Questions and comments?

1-888-396-2739

Label

CR1163 Primary Display Panel
(click image for full-size original)

BACITRACIN WITH ZINC
first aid antibiotic ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0470
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 500 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
PARAFFIN
PETROLATUM
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0470-1 72 BOX in 1 CASE contains a BOX
1 1 TUBE in 1 BOX This package is contained within the CASE (70000-0470-1) and contains a TUBE
1 28.4 g in 1 TUBE This package is contained within a BOX and a CASE (70000-0470-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 11/20/2018
Labeler — Cardinal Health (063997360)

Revised: 11/2022 Cardinal Health

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