Burnzone - Prescription Drug Labeling

Active ingredient

A list of the active, medicinal ingredients in the drug product.

Active Ingredient Lidocaine HCl 1%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.

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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.

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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.

Uses Temporarily relieves pain and itching due to minor burns, minor cuts, minor scrapes, sunburn, insect bites, rashes, minor skin irritations.

Purpose

Information about the drug product’s indications for use.

Purpose Topical Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.

BurnZone Pain Relieving Cream CARBOMER 934 CHAMAEMELUM NOBILE FLOWER CETOSTEARYL ALCOHOL CETYL ALCOHOL IODOPROPYNYL BUTYLCARBAMATE OLEIC ACID PANTHENOL TEA TREE OIL CLOVE OIL GLYCERIN GREEN TEA LEAF HYALURONATE SODIUM HYDROGENATED SOYBEAN LECITHIN MEDIUM-CHAIN TRIGLYCERIDES PEPPERMINT OIL POLYOXYL 20 CETOSTEARYL ETHER ALOE VERA LEAF LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE ALPHA-TOCOPHEROL ACETATE ALLANTOIN DIAZOLIDINYL UREA TROLAMINE WATER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.

Principal Display Panel

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.

Do not use in or near the eyes in large quantities, particularly over raw surfaces or blistered areas

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.

Keep out of reach of children If swallowed, get medical help or contact a Posion Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.

Other Information Store at room temperature. Avoid execssive heat or cold.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.

Questions? Toll-free 866-MEDZONE (866-633-9663) www.medzonecorp.com [email protected]

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.

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

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.

When using this product do not get into eyes

How supplied

Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.

Distributed by MedZone Products LLC Lenexa Kansas 66215 All Rights Reserved

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.

Warnings For external use only Drug Facts Label 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.