Active Ingredient
Neomycin 3.5mg
Polymyxin B 10,000 Units
Pramoxine HCL 10mg
Dual Action Cream
FDA Label NDC 69396-071
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceutical Usa Llc for the product Dual Action Cream (NDC 69396-071). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use, stop use and ask a doctor if:, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antibiotic
First Aid Antibiotic
External Analgesic
Uses
First Aid to help prevent infection 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
- 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
- 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
Questions
For Questions please call 1 888 296 9067
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 crimp for lot number and expiration date
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
* Please review the disclaimer below.
