SINGLE ANTIBIOTIC- bacitracin zinc ointment 
Safetec of America, Inc.

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61010-4404 Triple Antibiotic with Pain Relief

Drug Facts

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 havedeep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor ifthe condition persists or gets worse, or if 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 the affected area. Apply a small amount (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

Principal Display Panel – Tube Label

Safetec ®

Single Antibiotic Ointment

First Aid Infection Protection with Bacitracin Zinc

Net Wt. 1 oz. (28.4g)

Reorder No. 53301

Manufactured for: Safetec of America, Inc.

Buffalo, NY 14215 | 1-800-456-7077

Made in IndiaKD/503

Figure
SINGLE ANTIBIOTIC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4404
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-4404-128.4 g in 1 TUBE; Type 0: Not a Combination Product11/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00411/01/2019
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(61010-4404)

Revised: 2/2024
Document Id: 115cae29-9471-815f-e063-6294a90a25aa
Set id: 9993c204-6e61-4da3-90ef-2b7dfa09c920
Version: 2
Effective Time: 20240214
 
Safetec of America, Inc.