FDA Label for Burn Cream
View Indications, Usage & Precautions
Burn Cream Product Label
The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceuticals Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine HCL 0.5%
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.