AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Orazen Inc

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71927-016 American Safety & First Aid Triple Antibiotic

Active ingredients

(in each gram)

Bacitracin zinc 400 units

Neoycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B sulfate 5,000 units

Purpose

First Aid antibiotic

First Aid antibiotic

First Aid antibiotic

Uses

first aid to help prevent infection in

Warning

For external use only.

Do not use

Ask a doctor before use if you have

deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed contact a Poison Control Center right away.

Directions

Inactive Ingredient

Mineral Oil, Petrolatum, Water

image of pouch label

image of box label

AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.0035 g  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71927-016-03144 in 1 BOX10/17/2022
1NDC:71927-016-010.5 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00410/17/2022
Labeler - Orazen Inc (080916640)

Revised: 1/2024
Document Id: 0effc169-28e6-9eb0-e063-6394a90a432a
Set id: eb0df2da-1688-c477-e053-2995a90a74a2
Version: 2
Effective Time: 20240115
 
Orazen Inc