Bacitracin Zinc: Package Insert and Label Information

BACITRACIN ZINC- bacitracin zinc ointment
GERITREX LLC

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 500 units (each gram)………………..First Aid Antibiotic

Uses:

Helps prevent infection in: Minor cuts, scrapes, and/or burns

Warnings:

FOR EXTERNAL USE ONLY
Allergy Alert: Do not use if allergic to any of the ingredients.
Do not use in eyes or on large areas of the body.
Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
When using this product, do not use longer than 1 week, unless directed by a doctor.
Stop use and ask a doctor if condition lasts or gets worse, rahs or other allergic reaction develops.

KEEP OUT OF REACH OF CHILDREN
In the event of accidental ingestion, contact a Poison Control Center right away.

Directions:

Clean affected area. Apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily. May be covered with a sterile bandage.

Inactive Ingredients:

Mineral Oil and White Petrolatum

Other Information:

Store at controlled room temperature
59°-86°F (15°-30°C).

09
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15
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28
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BACITRACIN ZINC
bacitracin zinc ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-017
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [iU] in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54162-017-15 15 g in 1 TUBE None
2 NDC:54162-017-28 28 g in 1 TUBE None
3 NDC:54162-017-09 0.9 g in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 05/15/2014
Labeler — GERITREX LLC (112796248)
Registrant — GERITREX LLC (112796248)
Establishment
Name Address ID/FEI Operations
GERITREX LLC 112796248 manufacture (54162-017)

Revised: 01/2018 GERITREX LLC

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