Label: DERMASIL SENSITIVE- dimethicone lotion

  • 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 January 13, 2014

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  • SPL UNCLASSIFIED SECTION

    Dermasil® Labs has developed Dermasil® OTC Sensitive Skin Formula, a powerful skin treatment treatment and 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
  • 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.

    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, PEG-40 Stearate, Cetyl Alcohol, Sodium Hydroxide, Phenoxyethanol, Methylisothiazolinone, Iodopropynyl Butylcarbamate, Magnesium Aluminum Silicate, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Acetate, Acetylated Lanolin Alcohol, Carbomer, Disodium EDTA, 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.

    Figure

    Cruelty-Free. No Animal Testing.
    Please Recycle This Tube.

    www.riseintlgroup.com
    RISE INTERNATIONAL GROUP LLC
    Lodi, NJ 07644. Made in China
    ©RISE INTERNATIONAL GROUP LLC

  • Questions/Comments? 1-800-282-1813

  • Principal Display Panel - Tube Label Dermasil 10oz

    25% MORE
    Dermasil®
    LABS
    Pharmaceutical Research
    Controls Even Severe Dry Skin
    Skin Lipid & EFA Treatment
    Hypo-Allergenic
    Dermasil®
    Sensitive Skin Treatment
    LOTION
    10 FL OZ (296 ml)

    Principal Display Panel - Tube Label Dermasil 10oz
  • INGREDIENTS AND APPEARANCE
    DERMASIL SENSITIVE 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67143-2102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O) dimethicone0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM (UNII: I38ZP9992A)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CETYL OLEATE (UNII: 78K2L26L8N)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BORAGE OIL (UNII: F8XAG1755S)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SANDALWOOD OIL (UNII: X7X01WMQ5F)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    VANILLA (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67143-2102-4296 mL in 1 TUBE
    2NDC:67143-2102-6274 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/15/2009
    Labeler - Rise International Group LLC (011184988)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kingkey Daily Chemical Co., Ltd.545349263MANUFACTURE(67143-2102)
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