TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin and polymyxin b sulfate ointment 
Anicare Pharmaceuticals Pvt. Ltd

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 Antibiotic 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, cotton seed oil, olive oil,  sodium pyruvate, vitamin E, white petrolatum, hard parrafin, mineral oil

PRINCIPAL DISPLAY PANEL

Triple Antibiotic First Aid Antibiotic Ointment

NET WT 0.5 OZ (14 g)

label

TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC 
bacitracin zinc, neomycin and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-154
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)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47046-154-021 in 1 BOX12/09/2020
1NDC:47046-154-0114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/09/2020
Labeler - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(47046-154)

Revised: 12/2020
Document Id: b659bc8d-5c59-2503-e053-2995a90a217d
Set id: b659d3cf-97c4-5ca2-e053-2a95a90a9371
Version: 1
Effective Time: 20201213
 
Anicare Pharmaceuticals Pvt. Ltd