Bacitracin Zinc by H2-Pharma, LLC Bacitracin Zinc Ointment

Drug Details [pdf]

BACITRACIN ZINC- bacitracin zinc ointment
H2-Pharma, 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.

----------

Bacitracin Zinc Ointment

Drug Facts

Active ingredient (in each gram)

Bacitracin zinc USP, 500 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in minor

cuts
scrapes
burns

Warnings

For external use only.

Do not use

if you are allergic to any of the ingredients
in the eyes
over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

you need to use longer than one week
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 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°-30°C (59°-86°F)
before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

white petrolatum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

NDC: 61269-105-34

Bacitracin Zinc Ointment, USP
First aid antibiotic

For external use only
First aid antibiotic to help prevent infection in minor cuts, scrapes, and burns

Net wt. 0.5 oz (14 g)

H2 pharma

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

BACITRACIN ZINC
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61269-105
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Product Characteristics
Color	WHITE (clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 61269-105-34	1 in 1 CARTON	05/10/2021	07/31/2024
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 61269-105-56	1 in 1 CARTON	06/29/2021	10/31/2024
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333B	05/10/2021	10/31/2024

Labeler - H2-Pharma, LLC (028473634)

Revised: 2/2023

Document Id: 0f6793ee-6f8a-4afb-8ba5-44345960859b

Set id: 15eb3bf2-3a89-4381-8b05-9a123ec04dd1

Version: 5

Effective Time: 20230207