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TCX Skincare (Theraceutix, LLC)

Available Formats

Dosage Form Package Information Links
CREAM 59 mL in 1 JAR (49449-100-01) Label Information
CREAM 9 mL in 1 JAR (49449-100-02) Label Information

Complete TCX Skincare Information

  • Active ingredient

    Colloidal Oatmeal 2%


  • Purpose

    Skin protectant


  • Uses

    • Temporarily protects and helps relieve minor skin irritation and itching due to dry skin and eczema

  • Warnings

    • For external use only

    Keep out of reach of children.

    When using this product:

    • Do not get into eyes
    • Stop use and ask doctor if condition worsens

  • Directions

    • Apply to affected areas of skin twice daily

  • Inactive ingredients

    Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Cetyl Palmitate, Dimethicone, DMDM Hydantoin, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Mineral Oil, Octyldodecanol, PEG-40 Stearate, Phenoxy Ethanol, Sodium Hydroxide, Water


  • Package/Label Principal Display Panel - Carton Label

    ECZEMA AND DRY SKIN RELIEF
    Skin Protectant

    tcx skincare®
    Unique Hydromimeticsâ„¢

    2 fl oz/59 mL

    tcx skincare® Unique Hydromimeticsâ„¢ presents

    Hydromimeticsâ„¢, a natural breakthrough clinically-proven to temporarily relieve symptoms associated with eczema and dry skin. A superior, steroid-free, natural formula developed by doctors. Perfect for face, body and those with sensitive skin.

    Fragrance and paraben free.Tested by immunologists.Non-comedogenic.

    tcxskincare.com

    Carton Label

    Carton Label


  • Package/Label Principal Display Panel - Sample Label

    tcx skincare®
    Unique Hydromimeticsâ„¢

    0.3 oz

    Eczema and Dry Skin Relief
    Skin Protectant

    Directions: Apply to affected areas of skin twice daily

    SAMPLE NOT FOR RESALE

    tcxskincare.com

    Sample Label

    Sample Label


  • INGREDIENTS AND APPEARANCE
    TCX SKINCARE 
    colloidal oatmeal cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49449-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 2 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49449-100-01 59 mL in 1 JAR
    2 NDC:49449-100-02 9 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 05/17/2012
    Labeler - Theraceutix, LLC (078353793)
    Establishment
    Name Address ID/FEI Business Operations
    Fragrance Manufacturing, Inc. 793406000 MANUFACTURE(49449-100)