Label: THERAPLEX ECZEMA THERAPY- oatmeal cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active Ingredient

    Colloidal Oatmeal 1%

    Purpose

    Skin Protectant

  • Uses

    temporarily protects and helps relieve minor skin irritation and itching due to:

    • eczema
    • rashes
  • Warnings

    For external use only

    When using this product

    do not get into eyes.

    Stop 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 as needed, or as directed by your doctor.

  • Other information

    • store at room temperature
    • keep from freezing
  • Inactive Ingredients

    cyclomethicone, microcrystalline wax, petrolatum (special fraction)

  • Questions?

    call 1-888-437-2753

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    THERAPLEX ECZEMA THERAPY 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82280-816
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82280-816-00170.1 g in 1 JAR; Type 0: Not a Combination Product01/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/10/2022
    Labeler - THERAPLEX, LLC (118005210)
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