Label: ULTIMATE SKIN PROTECTANT DERMA SHIELD- dimethicone aerosol

  • 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 October 4, 2019

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Dimethicone 2.7% Skin Protectant

  • PURPOSE

    Uses

    • Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
    • Helps prevent and protect from the drying effects of wind and cold weather

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Stop use and ask a doctor if:

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

    Warnings

    For external use only

    Flammable:

    • Do not use near flame or spark or while smoking
    • Contents under pressure
    • Do not puncture or incinerate
    • Do not store at temperature above 120°F
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply as needed
    • Children under 6 months: ask a doctor
    • Wash and dry skin area
    • Shake can vigourously
      • Invert can and apply "golf Ball" size amount in palm
      • Rub thoroughly onto the skin
      • Allow to dry
  • INACTIVE INGREDIENT

    Inactive ingredients Water, Propane, Butane, Palmitic acid, Palm Kernal acid, Isopropyl Myristate, Glycerin, VP/VA Copolymer, Isobutane, Triethanolamine, Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Hydroxyethylcellulose, Perfluorianted Polyether, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Lanolin, Tetrasodium EDTA, Propylene Glycol Diazolidinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate,Citric Acid.

  • PRINCIPAL DISPLAY PANEL

    Benchmark's

    DermaShield

    The Ultimate Skin Protectant

    Net Weight 17 oz(1lb 1 oz) (482g)

    17 oz -6 US

  • INGREDIENTS AND APPEARANCE
    ULTIMATE SKIN PROTECTANT DERMA SHIELD 
    dimethicone aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70233-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOBUTANE (UNII: BXR49TP611)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    LANOLIN (UNII: 7EV65EAW6H)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PERFLUOROPOLYMETHYLISOPROPYL ETHER (UNII: X6324K3MBW)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANE (UNII: T75W9911L6)  
    BUTANE (UNII: 6LV4FOR43R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70233-010-01482 g in 1 CAN; Type 0: Not a Combination Product10/14/2019
    2NDC:70233-010-02170 g in 1 CAN; Type 0: Not a Combination Product10/14/2019
    3NDC:70233-010-0357 g in 1 CAN; Type 0: Not a Combination Product10/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/14/2019
    Labeler - Fleet Laboratories LTD (217269489)
    Establishment
    NameAddressID/FEIBusiness Operations
    FLEET LABORATORIES LTD217269489manufacture(70233-010)
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