TRIPLE ANTIBIOTIC FIRST AID- bacitracin zinc, neomycin and polymyxin b sulfate ointment 
Universal Distribution Center LLC

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 First Aid Ointment

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U

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 on

Stop use and consult a doctor if the condition persists or gets worse, or if 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

Other Information

Inactive Ingredients

Cocoa butter, Petrolatum, Cotton seed oil, Olive oil, Tocopheryl acetate, Sodium pyruvate.

PRINCIPAL DISPLAY PANEL

Triple Antibiotic First Aid Ointment

NET WT 0.5 OZ (14 g)

image of package label

TRIPLE ANTIBIOTIC FIRST AID 
bacitracin zinc, neomycin and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-019
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)  
PETROLATUM (UNII: 4T6H12BN9U)  
COTTONSEED OIL (UNII: H3E878020N)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM PYRUVATE (UNII: POD38AIF08)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-019-371 in 1 BOX02/14/2022
1NDC:52000-019-3614 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/15/2015
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-019)

Revised: 2/2022
Document Id: d882e909-0266-2490-e053-2995a90a9487
Set id: dbc66ae7-6c0a-4fc3-b7a7-78e4656a29c0
Version: 3
Effective Time: 20220221
 
Universal Distribution Center LLC