Label: DERMASIL DRYSKIN- dimethicone lotion

  • NDC Code(s): 76184-0101-1, 76184-0101-2, 76184-0101-3, 76184-0101-4, view more
    76184-0101-5, 76184-0101-6, 76184-0101-7, 76184-0101-8
  • Packager: Fantasia Beauty LLC
  • 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 August 30, 2017

If you are a consumer or patient please visit this version.

  • 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 Dryskin 7.25 Tube Label

    Dermasil®

    LABS

    Pharmaceutical Research

    Controls Even Sever Dry Skin

    Skin Lipid & EFA Treatment

    Hypo-Allergenic

    Dermasil®

    Dry Skin Treatment

    ORIGINAL LOTION

    7.25 FL. OZ. (214 ml)

    Principal Display Panel - Dermasil Dryskin 7.25 Tube Label
  • 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
  • Principal Display Panel - Dermasil Original 8 Bottle 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. (1/2 PINT, 237 ml)

    Principal Display Panel - Dermasil Original 8 Bottle Label
  • Principal Display Panel - Dermasil Dry Skin 9.25 Tube Label

    VALUE
    SIZE

    Dermasil®

    LABS

    Pharmaceutical Research

    Controls Even Severe Dry Skin

    Skin Lipid & EFA Treatment

    Hypo-Allergenic

    Dermasil®

    Dry Skin Treatment

    ORIGINAL LOTION

    9.25 FL. OZ. (274 ml)

    Principal Display Panel - Dermasil Dry Skin 9.25 Tube Label
  • Principal Display Panel - Dermasil Dryskin 10 Tube Label

    Dermasil®

    LABS

    Pharmaceutical Research

    Controls Even Severe Dry Skin

    Skin Lipid & EFA Treatment

    Hypo-Allergenic

    Dermasil®

    Dry Skin Treatment

    ORIGINAL LOTION

    10 FL. OZ. (296 ml)

    Principal Display Panel - Dermasil Dryskin 10 Tube Label
  • Principal Display Panel - Dermasil Dryskin 10 Bottle Label

    Dermasil®

    LABS

    Pharmaceutical Research

    Controls Even Severe Dry Skin

    Skin Lipid & EFA Treatment

    Hypo-Allergenic

    Dermasil®

    Dry Skin Treatment

    ORIGINAL LOTION

    10 FL. OZ. (3/5 PINT, 296 ml)

    Principal Display Panel - Dermasil Dryskin 10 Bottle Label
  • Principal Display Panel - Dermasil Dryskin 14.5 Bottle Label

    Dermasil®

    LABS

    Pharmaceutical Research

    Controls Even Severe Dry Skin

    Skin Lipid & EFA Treatment

    Hypo-Allergenic

    Dermasil®

    Dry Skin Treatment

    ORIGINAL LOTION

    14.5 FL. OZ. (0.9 PINT, 429 ml)

    Principal Display Panel - Dermasil Dryskin 14.5 Bottle Label
  • Principal Display Panel - Dermasil Dryskin 18.1 Bottle Label

    25 %
    MORE

    Dermasil®

    LABS

    Pharmaceutical Research

    Controls Even Severe Dry Skin

    Skin Lipid & EFA Treatment

    Hypo-Allergenic

    Dermasil®

    Dry Skin Treatment

    ORIGINAL LOTION

    18.1 FL. OZ. (1.1 PINT, 535 ml)

    Principal Display Panel - Dermasil Dryskin 18.1 Bottle 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:76184-0101-1214 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
    2NDC:76184-0101-2236 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
    3NDC:76184-0101-3237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
    4NDC:76184-0101-4274 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
    5NDC:76184-0101-5296 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2017
    6NDC:76184-0101-6296 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
    7NDC:76184-0101-7429 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
    8NDC:76184-0101-8535 mL in 1 BOTTLE; Type 0: Not a Combination Product08/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/30/2017
    Labeler - Fantasia Beauty LLC (037273190)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Kingkey Fine Chemical Co., Ltd.545349263MANUFACTURE(76184-0101)