TRIPLE ANTIBIOTIC WITH PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment 
Safetec of America, Inc.

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61010-4401-1, Triple Antibiotic with Pain relief

Drug Facts

Active Ingredients (in each gram)

Bacitracin Zinc (500 units)

Neomycin Sulfate 5mg (3.5mg Neomycin)

Polymyxin B Sulfate (5000 units)

Pramoxine Hydrochloride (10mg)

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Pain Reliever

Uses

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

Warnings

For external use only

Do not use

  • In the eyes
  • If you are allergic to any of the ingredients
  • Over large areas of the body
  • 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 if

  • The 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 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

White Petrolatum

Principal Display Panel - 1 oz. Tube Label

Safetec®

Triple Antibiotic Ointment
with Pain Relief

Net Wt. 1 oz. (28.4g)

Reorder No. 53206

Manufactured for: Safetec of America, Inc.
Buffalo, NY 14215 | 1-800-456-7077

Made in IndiaKD/503

Principal Display Panel - 1 oz. Tube Label
TRIPLE ANTIBIOTIC WITH PAIN RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [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
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-4401-128.4 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, Inc874965262manufacture(61010-4401)

Revised: 2/2024
Document Id: 118650cb-1aeb-b30a-e063-6394a90aff5a
Set id: ca1df4a0-844d-4b1d-b972-f2704a8ebbab
Version: 2
Effective Time: 20240216
 
Safetec of America, Inc.