PREMIER VALUE MAX STRENGTH ANTIBIOTIC PLUS PAIN RELIEF- premier value neomycin sulfate, polymyxin b sulfate, pramoxine hcl cream 
Pharmacy 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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Maximum Strength Antibiotic Cream plus Pain Relief

DRUG FACTS

Active Ingredient

Neomycin Sulfate 3.5mg

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B Sulfate 10,000 Units

Purpose

First Aid Antibiotic

Active Ingredient

Pramoxine HCL 10mg

Purpose

External Analgesic

Uses

First Aid to help prevent infection in minor:

Warnings

For external use only. Do not use:

Ask a Doctor before Use

Ask Doctor before use if you have:

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 Ingredient:

Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl Sterate, Light Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Purified Water, Sodium Lauryl Sulfate.

Questions or Comments

Call 1-866-923-4914

This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the regisgtered trademark Neosporin® Plus Pain Relief.

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

Product of PRC

Packaging

pv antibiotic cream + pain 05oz-PV03636

PREMIER VALUE MAX STRENGTH ANTIBIOTIC PLUS PAIN RELIEF 
premier value neomycin sulfate, polymyxin b sulfate, pramoxine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-296
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
WATER (UNII: 059QF0KO0R)  
ETHYLPARABEN (UNII: 14255EXE39)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-296-051 in 1 BOX09/22/2019
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/22/2019
Labeler - Pharmacy Value Alliance LLC (101668460)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 5/2023
Document Id: fb458801-6b75-26f7-e053-6294a90a7c6d
Set id: 9767821e-054b-3bd3-e053-2a95a90a4b0e
Version: 2
Effective Time: 20230509
 
Pharmacy Value Alliance LLC