Label: ECZEMA THERAPY- colloidal oatmeal cream

  • NDC Code(s): 72381-103-01
  • Packager: Hamilton Therapeutics, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 February 10, 2023

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  • ACTIVE INGREDIENT

    Active ingredient Purpose
    Colloidal Oatmeal 1% ..............................Skin Protectant

  • PURPOSE

    Uses

    Temporarily protects and helps relieve minor skin
    irritation and itching due to: • Eczema • Rashes

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical
    help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    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

  • WARNINGS

    Warnings For external use only. When using this product • Avoid contact with eyes.

  • DOSAGE & ADMINISTRATION

    Directions • Apply as needed to affected areas.
    • Use on mild to moderate eczema, or as directed by a physician.

  • INACTIVE INGREDIENT

    Inactive ingredients Water, Butyrospermum Parkii (Shea) Butter, Bisabolol, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Honey, Sclerocarya Birrea Seed Oil, Glyceryl Stearate, Glycerin, Cetearyl Alcohol, Sorbitan Stearate, Sorbityl Laurate, Stearyl Alcohol, Potassium Cetyl Phosphate, Panthenol, Allantoin, Tocopherol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Niacinamide, Vegetable Oil, Sodium Hyaluronate, Xanthan Gum, Sodium PCA, Tetradecane, Arginine, Cetyl Phosphate, Phenethyl Alcohol, Sodium Dehydroacetate, Caprylhydroxamic Acid.

  • PRINCIPAL DISPLAY PANEL

    Eczema Therapy

    8 FL OZ/ 236mL

    Eczema thera tube

  • INGREDIENTS AND APPEARANCE
    ECZEMA THERAPY 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72381-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITYL LAURATE (UNII: 23XPH3M9LR)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ARGININE (UNII: 94ZLA3W45F)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ALCOHOL (UNII: 3K9958V90M)  
    LEMON PEEL (UNII: 72O054U628)  
    SAGE (UNII: 065C5D077J)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
    CORN OIL (UNII: 8470G57WFM)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TETRADECENE (UNII: FW23481S7S)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HONEY (UNII: Y9H1V576FH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    THYME (UNII: CW657OBU4N)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72381-103-01236 mL in 1 TUBE; Type 0: Not a Combination Product06/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/11/2018
    Labeler - Hamilton Therapeutics, Inc. (099419360)
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