Label: DERMASIL DRY SKIN LOTION TREATMENT LOTION - dimethicone lotion

  • NDC Code(s): 17500-2101-4
  • Packager: Kingkey Daily Chemical Co LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/09

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  • SPL UNCLASSIFIED SECTION

    Dermasil® Labs has developed Dermasil® OTC pharmaceuticals skincare, a powerful dry skin treatment and skin protectant.
    This lotion contains four systems to control and provide long-lasting relief from severe dry skin:
    Occlusives to block moisture loss from the skin's surface
    Humectant to bind water in the skin's outermost layers
    Skin Lipids to enhance the skin's natural ability to retain moisture
    EFA's an important component of the skin's moisture barrier

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  • INDICATIONS & USAGE

    Indications: Suitable for severe dry skin, and control of symptoms such as chapping, cracking, flaking, roughness, redness, soreness, and the itching associated with dry skin.

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active Ingredient

    Dimethicone 1 %

    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.
    • 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.
    • Keep out of reach of children.
      If swallowed, get medical help or contact a Poison Control center right away.

    Directions

    • Apply as needed

    Inactive Ingredients Water (Aqua), Petrolatum, Mineral Oil (Parraffinum Liquidum),Glycerin, Stearic Acid, Glycol Stearate, Glyceryl Stearate, Triethanolamine, PEG-40 Stearate, Cetyl Alcohol, DMDM Hydantoin, Magnesium Aluminum Silicate, Methylparaben, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Acetate, Acetylated Lanolin Alcohol, Carbomer, Propylparaben, Disodium EDTA, Geranium Maculatum Oil, Lecithin, Borago Officinalis Seed Oil, Cholesterol, Ascorbyl Palmitate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ethylene Brassylate, Santalum Album (Sandalwood) Oil, Rosa Damascena Extract, Vanilla Planifolia Fruit Extract

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - 10 FL.0Z (5/8 PINT. 296 ml)

    Tube Label Dermasil 10oz
    25% MORE
    Dermasil®
    LABS
    Pharmaceutical Research
    Controls Even Severe Dry Skin
    Skin Lipid & EFA Treatment
    Hypo-Allergenic
    Dermasil®
    Dry Skin Treatment
    ORIGINAL LOTION
    10 FL.0Z (5/8 PINT. 296 ml)

    Principal Display Panel - 10 FL.0Z (5/8 PINT. 296 ml)
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  • INGREDIENTS AND APPEARANCE
    DERMASIL   DRY SKIN LOTION TREATMENT LOTION
    dimethicone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17500-2101
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 1 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    PETROLATUM  
    MINERAL OIL  
    GLYCERIN  
    STEARIC ACID  
    GLYCOL STEARATE  
    GLYCERYL MONOSTEARATE  
    CETYL ALCOHOL  
    MAGNESIUM ALUMINUM SILICATE  
    METHYLPARABEN  
    HELIANTHUS ANNUUS  
    CETYLPYRIDINIUM ACETATE  
    CARBOMER HOMOPOLYMER TYPE C  
    PROPYLPARABEN  
    EDETATE DISODIUM  
    LECITHIN, SOYBEAN  
    BORAGE  
    CHOLESTEROL  
    ASCORBYL PALMITATE  
    ALMOND  
    VANILLA  
    GERANIUM EXTRACT  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17500-2101-4 296 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 10/15/2009
    Labeler - Kingkey Daily Chemical Co LTD (001181027)
    Establishment
    Name Address ID/FEI Business Operations
    Kingkey Daily Chemical Co LTD 001181027 MANUFACTURE
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