TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate and 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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Triple Antibiotic

Active Ingredients (in each gram)

Bacitracin Zinc         400 units

Neomycin Sulfate    5 mg

(3.5 mg of Neomycin base)

Polymyxin B Sulfate 5000 units

Purpose

First aid antibiotic

Uses

first aid to help prevent infection in

Warnings

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, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment

Bacitracin Zinc, Neomycin Sulfate and Polymyxin B Sulfate

First Aid Antibiotic Ointment

NET WT 0.5 oz (14.2 g)

image of package label

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-003
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) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
COCOA BUTTER (UNII: 512OYT1CRR)  
COTTONSEED OIL (UNII: H3E878020N)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM PYRUVATE (UNII: POD38AIF08)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71927-003-021 in 1 CARTON07/12/2018
114.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/12/2018
Labeler - Orazen Inc (080916640)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(71927-003)

Revised: 2/2022
Document Id: d8c318c1-5787-0e62-e053-2a95a90a8618
Set id: f9d698e2-a122-48bb-8298-38c55ef36874
Version: 3
Effective Time: 20220224
 
Orazen Inc