DUAL ACTION CREAM- neomycinsulfate,polymyxinbsulfate,pramoxinehcl cream

Dual Action Cream by

Drug Labeling and Warnings

Dual Action Cream by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceutical USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 iand for temporary relief of pain or discomfort in minor cuts, scrapes and burns.

Warnings

For external use only. Do not use:

• If you are allergic to any of the ingredients
• in the eyes
• over large areas of the body

Ask a Doctor before Use

Ask 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
• Symptoms persist for more than 1 week or clear up and occur within a few days.
• A rash or other allergive reaction develops

Keep out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children 2 years of age and older

• Clean the affected area
• 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

Children under 2 years of age: ask a doctor

Questions

For Questions please call 1 888 296 9067

Other Information

• Store at 20° to 25°C (68° to 77°F)

Inactive Ingredient:

Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monosterate, 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

Packaging

LABEL

INGREDIENTS AND APPEARANCE

DUAL ACTION CREAM 
neomycinsulfate,polymyxinbsulfate,pramoxinehcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-071-01	1 in 1 BOX	01/22/2021
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-071-44	4 in 1 BOX	12/02/2024
2		28.4 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69396-071-22	2 in 1 BOX	08/23/2025
3		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	01/06/2021

Labeler - Trifecta Pharmaceutical USA LLC (079424163)