Label: DERMASIL ADVANCED- dimethicone lotion

  • 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, METHYLISOTHIAZOLINONE, IODOPROPYNYL BUTYLCARBAMATE, FRAGRANCE, 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, NIACINAMIDE, INOSITOL.

  • Principal Display Panel - Dermasil Advanced 8 Tube Label

    Dermasil®

    LABS

    Pharmaceutical Research

    Controls Even Sever Dry Skin

    Skin Lipid & EFA Treatment

    Hypo-Allergenic

    Dermasil®

    Advanced Treatment

    CREAMY LOTION

    8 FL OZ (236 ml)

    Principal Display Panel - Dermasil Advanced 8 Tube Label
  • INGREDIENTS AND APPEARANCE
    DERMASIL ADVANCED 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76184-0100
    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)  
    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)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    INOSITOL (UNII: 4L6452S749)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76184-0100-2236 mL in 1 TUBE; Type 0: Not a Combination Product08/30/201712/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/30/201712/31/2024
    Labeler - Fantasia Beauty LLC (037273190)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Kingkey Fine Chemical Co., Ltd.545349263MANUFACTURE(76184-0100)
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