TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Premier Value Alliance 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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Premier Value Triple Antibiotic Ointment

Active ingredients (each gram contains)

Bacitracin zinc 400 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

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

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

Warnings For external use only.

Do not use ● in the eyes ● over large areas of the body

● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds ● animal bites ● serious burns.

Stop use and ask a doctor if condition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops

Inactive ingredient:Cetyl Alcohol, Light Mineral Oil, Squalane, Stearic Acid, Vitamin E and Petrolatum

Other information

● To open: unscrew cap, pull tab to remove foil seal

● store at 20° to 25°C ( 68° to 77°F)

● see carton or tube for lot number and expiration date.

Questions? Call 1-866-923-4914

Other Information

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087

Product of PRC

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Directions

Clean the affected area and dry thoroughly.

Apply a small amount of this product ( an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.

May be covered with a sterile bandage.

Packaging

pv triple antibiotic 1oz PV03642

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-319
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
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SQUALANE (UNII: GW89575KF9)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-319-011 in 1 BOX01/10/2019
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/10/2019
Labeler - Premier Value Alliance LLC. (101668460)
Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)

Revised: 5/2023
Document Id: fb455461-db4e-fcb9-e053-6294a90a1c60
Set id: ab863d90-1a8f-3c1f-e053-2a95a90aa0a7
Version: 2
Effective Time: 20230509
 
Premier Value Alliance LLC.