TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]

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TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]
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NDC 49449-100-01, 49449-100-02
Set ID c3be950b-28cf-47c2-9570-ebd46e43b1ba
Category HUMAN OTC DRUG LABEL
Packager Theraceutix, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

    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 HYDROMIMETICS™

    2 fl oz/59 mL

    image-01

    Carton Label

  • Package/Label Principal Display Panel - Sample Label

    tcx skincare®
    UNIQUE HYDROMIMETICS™

    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

    image-02

    Sample Label

  • INGREDIENTS AND APPEARANCE
    TCX SKINCARE 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49449-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49449-100-0159 g in 1 JAR; Type 0: Not a Combination Product05/17/2012
    2NDC:49449-100-029 g in 1 JAR; Type 0: Not a Combination Product05/17/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/17/2012
    Labeler - Theraceutix, LLC (078353793)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE(49449-100)
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