Label: ETHEREAL SKIN CALMING MOISTURIZING CREAM- dimethicone cream

  • 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 October 12, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Dimethicone 2.0%

  • PURPOSE

    Purpose:

    Skin Protectant

  • INDICATIONS & USAGE

    Uses:

    Relieves and helps prevent dry, itchy skin. Specially formulated to moisturize, calm, and soothe your skin.

  • WARNINGS

    Warnings:

    For external use only

    When using this product, avoid contacting with eyes

  • STOP USE

    In case of accidental ingestion get medical help or contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Direction:

    Smooth over irritated, dry skin daily or as needed. For best results apply immediately after shower or/and bath.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Glycerin, Cetyl Palmitate, Mineral Oil, Colloidal Oatmeal, Caprylic/Capric Triglyceride, Octyldodecanol, Cetyl Alcohol, Glyceryl Stearate, PEG-40 Stearate,  Carbomer, Sodium Hydroxide, Phenoxyethanol, Benzyl Alcohol, Methylparaben, Propylparaben, DMDM Hydantoin

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ETHEREAL SKIN CALMING MOISTURIZING CREAM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70990-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70990-003-01252 mL in 1 TUBE; Type 0: Not a Combination Product10/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/19/2016
    Labeler - Donegal Bay Ltd (068443618)
    Registrant - Donegal Bay Ltd (068443618)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU KARIC COMMODITIES CO., LTD526884335manufacture(70990-003)
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