Label: SKINDURANCE- dimethicone 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 April 30, 2015

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  • Active Ingredient

    Dimethicone (1%)

  • Purpose

    Skin Protectant

  • Uses

    • Helps prevent and temporarily protects and helps relieve chafed, 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 doctor 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 • animal bites • serious burns.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    • Apply as needed

  • Inactive Ingredients

    Caprylic/Capric Triglycerides, C18-36 Acid Triglycerides, Tribehenin, Aloe Barbadensis Leaf Extract, Jojoba Wax, Allantoin, Tocopheryl Acetate, Retinyl Palmitate, Hamamelis Virginiana (Witch Haxel) Leaf Extract

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions or Comments?

    Call 301-247-9677

  • PRINCIPAL DISPLAY PANEL

    Front LabelBack Label

  • INGREDIENTS AND APPEARANCE
    SKINDURANCE 
    dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69802-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69802-025-017090 mg in 1 APPLICATOR; Type 0: Not a Combination Product05/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2015
    Labeler - Skindure, LLC (079763592)
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