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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 labelimage 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:71927-016-0225 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 finalpart333B10/17/2022
Labeler - Orazen Inc (080916640)

Revised: 10/2022
Document Id: eb0d108f-42c0-3364-e053-2a95a90a4542
Set id: eb0d108f-42bf-3364-e053-2a95a90a4542
Version: 1
Effective Time: 20221015
 
Orazen Inc