BURNZONE- pain relieving cream cream 
MedZone Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 onlyDrug 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.

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

Distributed by MedZone Products LLC

Lenexa Kansas 66215 All Rights Reserved

Principal Display Panel

BURNZONE 
pain relieving cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-621
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70338-621-123.6 g in 1 POUCH; Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2016
Labeler - MedZone Products LLC (080083739)
Registrant - Richard Hamer Associates LLC (067731889)
Establishment
NameAddressID/FEIBusiness Operations
Biomed Laboratories LLC055329696manufacture(70338-621) , pack(70338-621)
Establishment
NameAddressID/FEIBusiness Operations
Microconsult Inc.062183608analysis(70338-621)
Establishment
NameAddressID/FEIBusiness Operations
Ceutical Laboratories Inc.789485153analysis(70338-621)

Revised: 2/2018
Document Id: 65085ba2-e779-8823-e053-2991aa0a90d0
Set id: 37898703-be54-2853-e054-00144ff88e88
Version: 2
Effective Time: 20180212
 
MedZone Products LLC