SINGLE ANTIBIOTIC WITH BACITRACIN- bacitracin zinc ointment

Single Antibiotic with Bacitracin by

Drug Labeling and Warnings

Single Antibiotic with Bacitracin by is a Otc medication manufactured, distributed, or labeled by Randob Labs Ltd., Safetec of America, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each gram)

Bacitracin zinc (500 units bacitracin)

Purpose

First Aid Antibiotic

Uses:

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

Warnings:

For external use only. Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center directly.

Do Not Use:

• in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns
• for more than 1 week unless directed by a doctor
• if allergic to any of the ingredients

Stop use, ask a doctor if:

• condition persists or gets worse
• a rash or allergic reaction develops

Directions:

• clean affected area
• apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily
• may cover with a sterile bandage

Inactive ingredients:

mineral oil, petrolatum

Questions or Comments?

1-800-456-7077

First Aid Antibiotic

NDC: 52412-750-10

CrossingWell Consumer Health

Bacitracin Ointment with Zinc

First Aid Antibiotic to Help Prevent Infection

Net Wt 1oz (28g)

INGREDIENTS AND APPEARANCE

SINGLE ANTIBIOTIC WITH BACITRACIN 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52412-750
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52412-750-05	1 in 1 BOX	12/30/2024
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 52412-750-10	1 in 1 BOX	12/30/2024
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	12/30/2024

Labeler - Randob Labs Ltd. (061995007)

Registrant - Safetec of America (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	manufacture(52412-750)