Label: BENCHMARKS 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 2, 2023

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  • ACTIVE INGREDIENT

    Active ingredient

    Dimethicone, 2.7%

  • PURPOSE

    Purpose

    Skin protectant

  • KEEP OUT OF REACH OF CHILDREN

    Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns
    • Keep out of reach of children
  • INDICATIONS & USAGE

    Uses

    • helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin
    • helps prevent and protect from the drying effects or wind and cold weather
  • 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 oF
  • DOSAGE & ADMINISTRATION

    Directions

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

    Inactive ingredients

    Water, Propane, Butane, Palmitic acid, Palm Kernal acid, Isopropyl Myrisate, 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 Diazolindinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    Derma Shield 17 oz Aerosol

  • INGREDIENTS AND APPEARANCE
    BENCHMARKS DERMA SHIELD 
    dimethicone aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70557-002
    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
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOBUTANE (UNII: BXR49TP611)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PERFLUOROPOLYMETHYLISOPROPYL ETHER (UNII: X6324K3MBW)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANE (UNII: T75W9911L6)  
    BUTANE (UNII: 6LV4FOR43R)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70557-002-03482 g in 1 CAN; Type 0: Not a Combination Product04/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/27/2016
    Labeler - Delta Kits Inc (180476731)
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