Label: BLISTERZONE- skin protectant stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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

    Dimethicone 1%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the druing effects of wind and cold weather,

  • Warnings

    Back PanelFor external use only.

    When using this product

    • do not get into eyes.

    Stop use and ask a physician if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on:

    • deep or puncture wounds
    • serious burns
    • animal bites

    Keep out of reach of chlidren

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally as needed before athletic activity or to areas of repetitive friction/rubbing

  • Inactive Ingredients

    Aloe Vera Leaf, Alpha-Tocopheryl Acetate, 1-Butene, C18-36 Acid Triglyceride, Ethylene, Eucalyptus Oil, Ginkgo, Levomenol, Medium-Chain Triglycerides, Menthyl Lactate, Methylparaben, Mineral oil, Peppermint Oil, Petrolatum, Propylene, Propylparaben, Styrene, Tea Tree Oil, Tribehenin, Yellow Wax

  • Other Information

    Store at room temperature. Avoid excessive heat.

  • 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

    BlitserzonePDP

  • INGREDIENTS AND APPEARANCE
    BLISTERZONE 
    skin protectant stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-611
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    STYRENE (UNII: 44LJ2U959V)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    1-BUTENE (UNII: LY001N554L)  
    ETHYLENE (UNII: 91GW059KN7)  
    C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GINKGO (UNII: 19FUJ2C58T)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE (UNII: AUG1H506LY)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70338-611-0023 g in 1 APPLICATOR; Type 0: Not a Combination Product07/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/01/2016
    Labeler - MedZone Products LLC (080083739)
    Registrant - Richard Hamer Associates LLC (067731889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biomed Laboratories LLC055329696manufacture(70338-611) , pack(70338-611)
    Establishment
    NameAddressID/FEIBusiness Operations
    MicroConsult Inc062183608analysis(70338-611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ceutical Laboratories Inc789485153analysis(70338-611)
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