DUAL ACTION CREAM- neomycinsulfate,polymyxinbsulfate,pramoxinehcl cream 
Trifecta Pharmaceutical USA 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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Dual Action Cream

DRUG FACTS

Active Ingredient

Neomycin 3.5mg

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B 10,000 Units

Purpose

First Aid Antibiotic

Active Ingredient

Pramoxine HCL 10mg

Purpose

External Analgesic

Uses

First Aid to help prevent infection in minor cuts, scrapes and burns.

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

Questions

For Questions please call 1 888 296 9067

Other Information

Inactive Ingredient:

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

Distributed By

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

www.trifecta-pharma.com

Product of PRC

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

Packaging

dual action ointment pain

DUAL ACTION CREAM 
neomycinsulfate,polymyxinbsulfate,pramoxinehcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-071
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
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-23 (UNII: N72LMW566G)  
ETHYLPARABEN (UNII: 14255EXE39)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-071-011 in 1 BOX01/22/2021
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34701/06/2021
Labeler - Trifecta Pharmaceutical USA LLC (079424163)

Revised: 1/2023
Document Id: f276f813-a26b-42ad-e053-2a95a90a70fd
Set id: b84015ae-9c76-b1d7-e053-2a95a90a2cc8
Version: 3
Effective Time: 20230117
 
Trifecta Pharmaceutical USA LLC