Label: DERMASIL DRYSKIN- dimethicone lotion

  • NDC Code(s): 76184-0101-2, 76184-0101-3, 76184-0101-4
  • Packager: Fantasia Beauty LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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  • 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 to Hands and Body every day.
  • INACTIVE INGREDIENTS:

    WATER (AQUA), GLYCERIN, PETROLATUM, MINERAL OIL (PARAFFINUM LIQUIDUM), STEARIC ACID, GLYCOL STEARATE, GLYCERYL STEARATE, PEG-40 STEARATE, CETYL ALCOHOL, CETYL ACETATE, SODIUM HYDROXIDE, PHENOXYETHANOL, CARBOMER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DISODIUM EDTA, ACETYLATED LANOLIN ALCOHOL, GERANIUM MACULATUM OIL, METHYLISOTHIAZOLINONE, IODOPROPYNYL BUTYLCARBAMATE, MAGNESIUM ALUMINUM SILICATE, 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.

  • Principal Display Panel - Dermasil Original 8 Tube Label

    Dermasil®

    LABS

    Pharmaceutical Research

    Controls Even Severe Dry Skin

    Skin Lipid & EFA Treatment

    Hypo-Allergenic

    Dermasil®

    Dry Skin Treatment

    ORIGINAL LOTION

    8 FL OZ (236 ml)

    Principal Display Panel - Dermasil Original 8 Tube Label
  • INGREDIENTS AND APPEARANCE
    DERMASIL DRYSKIN 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76184-0101
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL OLEATE (UNII: 78K2L26L8N)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
    GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BORAGE OIL (UNII: F8XAG1755S)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    SANDALWOOD OIL (UNII: X7X01WMQ5F)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    VANILLA (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76184-0101-2236 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
    2NDC:76184-0101-3429 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2023
    3NDC:76184-0101-4535 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/30/2017
    Labeler - Fantasia Beauty LLC (037273190)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Kingkey Fine Chemical Co., Ltd.545349263MANUFACTURE(76184-0101)
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