Active Ingredient
Lidocaine HCL 0.5%
Burn Cream
FDA Label NDC 69396-105
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 Pharmaceuticals Usa Llc for the product Burn Cream (NDC 69396-105). 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, otc - active ingredient, uses, warnings, directions, inactive ingredients, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
First Aid Antiseptic
Otc - Active Ingredient
Benzalkonium Chloride 0.13%
Uses
Temporary Relief of pain associated with minor cuts, scrapes and burns.
Helps protect against harmful bacteria.
Warnings
For external Use Only
Do not use
- in eyes
- in large quantities
- over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
- for more than one week unless directed by a doctor
Directions
- Clean the affected area
- Apply a small amount not more than 3 times daily
- May be covered with a sterile bandage
Inactive Ingredients
Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, purified water, stearic acid, Triethanolamine.
Questions
To reorder:
Call 1-888-296-9067
Fax: 1-888-878-3609
Online: www.trifecta-pharma.com
Reorder No. 4050
Questions or Comments?
Call: 1-888-296-9067
Storage Information
- Store in cool dry area 15° to 25°C (59° to 77°F).
- tamper evident sealed packets
- do not use any opened or torn packets
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Other Information
Distributed By:
Trifecta Pharmaceuticals USA®
101 NE Third Ave. Ste 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
Otc - Purpose
First Aid Antiseptic
* Please review the disclaimer below.
