BURNZONE- pain relieving cream cream

BurnZone by

Drug Labeling and Warnings

BurnZone by is a Otc medication manufactured, distributed, or labeled by MedZone Products LLC, Richard Hamer Associates LLC, Biomed Laboratories LLC, Microconsult Inc., Ceutical Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCl 1%

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 info@medzonecorp.com

HOW SUPPLIED

Distributed by MedZone Products LLC

Lenexa Kansas 66215 All Rights Reserved

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURNZONE 
pain relieving cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70338-621
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
OLEIC ACID (UNII: 2UMI9U37CP)
PANTHENOL (UNII: WV9CM0O67Z)
TEA TREE OIL (UNII: VIF565UC2G)
CLOVE OIL (UNII: 578389D6D0)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70338-621-12	3.6 g in 1 POUCH; Type 0: Not a Combination Product	07/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2016

Labeler - MedZone Products LLC (080083739)

Registrant - Richard Hamer Associates LLC (067731889)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Laboratories LLC		055329696	manufacture(70338-621) , pack(70338-621)

Establishment
Name	Address	ID/FEI	Business Operations
Microconsult Inc.		062183608	analysis(70338-621)

Establishment
Name	Address	ID/FEI	Business Operations
Ceutical Laboratories Inc.		789485153	analysis(70338-621)