TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Safetec of America, Inc.

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61010-4400-2, Triple Antibiotic

Active ingredients

(in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)

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

  • internally
  • in eyes
  • 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 you are allergic to any of the ingredients

Stop use and ask a doctor if

  • a rash or allergic reaction develops
  • condition worsens or persists

Keep out of reach of children

If ingested, contact a Poison Control Center right away.

Directions

Inactive ingredient

petrolatum

Principal Display Panel – 28 g Tube Label

Safetec®

Triple
Antibiotic
Ointment

First Aid
Infection Protection

To Help Prevent Infection
in Minor Cuts, Scrapes,
and Burns

Net Wt. 1 oz. (28.4g)

Figure
TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-4400-228 g in 1 TUBE; Type 0: Not a Combination Product07/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00407/25/2022
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(61010-4400)

Revised: 2/2024
Document Id: 10aa746d-d831-277b-e063-6294a90ac9b8
Set id: 59494d5c-dd8a-431c-8e6a-4e1151ba7460
Version: 2
Effective Time: 20240205
 
Safetec of America, Inc.