TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment 
Acme United Corporation

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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First Aid Only Triple Antibiotic Ointment

• ACTIVE INGREDIENT

Bacitracin zinc 400 units

Neomycin sulfate 5 mg (equivalent to 3.5 mg. of neomycin base)

Polymyxin - B sulfate 5000 units

Active ingredient (in each gram)Purpose
Bacitracin Zinc 400 UnitsFirst Aid Antibiotic
Neomycin Sulfate 5mg (Equivalent to 3.5 mg of Neomycin base)First Aid Antibiotic
Polymyxin B Sulfate 5000 UnitsFirst Aid Antibiotic

• USES

First aid to help prevent infection in minor:

WARNINGS

For external use only

DO NOT USE

Do not use • in the eyes •over large areas of the body •if you are allergic to any of the ingredients

•longer than 1 week unless directed by a doctor •on deep lacerations or puncture wounds, animal bites, or serious burns

STOP USE AND ASK A DOCTOR IF

•condition persists or gets worse •a rash or allergic reaction occurs

•condition persists for more than 7 days

Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

Adults and Children Clean the affected area. Apply a small amount of product

(equal to the surface area of a fingertip) 1 to 3 times daily. May be covered with a sterile bandage.

OTHER INFORMATION

Store at 15°- 30°C (59°- 86°F)

INACTIVE INGREDIENT

White Petrolatum

Questions 1.800.835.2263

Carton Image Carton Image

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5610(NDC:50382-023)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [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:0924-5610-0225 in 1 CARTON08/05/2022
10.5 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0924-5610-000.5 g in 1 PACKET; Type 0: Not a Combination Product08/05/2022
3NDC:0924-5610-0112 in 1 CARTON08/05/2022
30.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/04/2022
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339repack(0924-5610) , relabel(0924-5610)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599repack(0924-5610) , relabel(0924-5610)

Revised: 8/2022
Document Id: e55caa58-5df7-2dc3-e053-2a95a90af7f7
Set id: e55cbf7e-c955-7f1a-e053-2a95a90a3f28
Version: 1
Effective Time: 20220803
 
Acme United Corporation