Label: DERMASIL DRYSKIN- dimethicone lotion

  • NDC Code(s): 73928-100-01
  • Packager: Kingkey MBC Life Technology Group Co., Ltd.
  • 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 July 14, 2023

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  • ACTIVE INGREDIENT

    Dimethicone 1%

  • PURPOSE

    Skin protectant

  • Use

    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.

  • Package Label - Principal Display Panel

    Dermasil®

    LABS

    Pharmaceutical Research

    Controls Even Severe Dry Skin

    Skin Lipid & EFA Treatmentimage description

    Hypo-Allergenic

    Dermasil®

    Dry Skin Treatment

    ORIGINAL LOTION

    8 FL OZ (236 ml)

    NDC: 73928-100-01

  • INGREDIENTS AND APPEARANCE
    DERMASIL DRYSKIN 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73928-100
    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 MONOSTEARATE (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:73928-100-01236 mL in 1 TUBE; Type 0: Not a Combination Product07/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/14/2023
    Labeler - Kingkey MBC Life Technology Group Co., Ltd. (545349263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kingkey MBC Life Technology Group Co., Ltd.545349263manufacture(73928-100)
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