Label: BURNZONE- pain relieving cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated February 12, 2018

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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

  • HOW SUPPLIED

    Distributed by MedZone Products LLC

    Lenexa Kansas 66215 All Rights Reserved

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    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)
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