Active Ingredient
Lidocaine HCl 1%
Burnzone
FDA Label NDC 70338-621
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medzone Products Llc for the product Burnzone (NDC 70338-621). 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, when using this product, stop use and ask a physician if, do not use, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
Temporarily relieves pain and itching due to minor burns, minor cuts, minor scrapes, sunburn, insect bites, rashes, minor skin irritations.
Warnings
For external use only
When Using This Product
- do not get into eyes
Stop Use And Ask A Physician If
- Allergic reaction occirs
- condition worsens or does not improve within 7 days
- symptoms clear up and return withina few days
- redness, irritation, swelling, pain or other symptoms begin or increase
Do Not Use
- in or near the eyes
- in large quantities, particularly over raw surfaces or blistered areas
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Posion Control Center right away.
Directions
dults and children 2 years of age and over: Apply to affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a physician.
Other Information
Store at room temperature. Avoid execssive heat or cold.
Inactive Ingredients
Allantoin, Aloe Vera Leaf, Alpha-Tocopheryl Acetate, Carboxypolymethylene, Chamaemelum Nobile Flower, Cetostearyl Alchol, Cetyl Alcohol, Clove Oil, Duazolidinyl Urea, Glycerin, Green Tea Leaf, Hyaluronate Sodium, Hydrogenated Soybean Lecithin, Iodopropynyl Butylcarbamate, Medium-Chain Triglycerides, Oleic Acid, Panthenol, Peppermint Oil, Polyoxyl 20 Cetostearyl Ether, Tea Tree Oil, Trolamine, Water
Questions?
Toll-free 866-MEDZONE (866-633-9663)
www.medzonecorp.com [email protected]
How Supplied
Distributed by MedZone Products LLC
Lenexa Kansas 66215 All Rights Reserved
* Please review the disclaimer below.
