Label: CHAFEZONE- skin protectant stick

  • Category: HUMAN OTC DRUG LABEL

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 December 31, 2021

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  • DRUG FACTS Active Ingredient

    Active IngredientPurpose
    Dimethicone 1%Skin Protectant

  • Purpose

    Skin Protectant

  • Uses:

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

  • Warnings

    For 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 children.

    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 Barbadensis Leaf Juice, Beeswax, Benzoic Acid, BHT, Bisabolol, Butylene/ethylene/styrene Copolymer, Caprylic Capric Triglyceride, C18-36 Acid Triglyceride, ethylene/propylene/styrene copolymer, ethylhexylglycerin, eucalyptus oil, ginkgo biloba leaf extract, glycereth-2 cocoate, glycerin, tea tree leaf oil, peppermint oil, Menthyl lactate, mineral oil, petrolatum, phenoxyethanol, tocopheryl acetate, tribehenin.

  • Other Information:

    Store at room temperature. Avoid excessive heat.

  • 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

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  • INGREDIENTS AND APPEARANCE
    CHAFEZONE 
    skin protectant stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-631
    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
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE (UNII: AUG1H506LY)  
    STYRENE (UNII: 44LJ2U959V)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    1-BUTENE (UNII: LY001N554L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70338-631-7043 g in 1 APPLICATOR; Type 0: Not a Combination Product07/01/2016
    2NDC:70338-631-0023 g in 1 PACKET; 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dhaliwal Laboratories LLC016754201manufacture(70338-631)
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