Label: ECZEMA THERAPY- colloidal oatmeal cream
- NDC Code(s): 72381-103-01
- Packager: Hamilton Therapeutics, Inc.
- 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 February 10, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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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
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INGREDIENTS AND APPEARANCE
ECZEMA THERAPY
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72381-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72381-103-01 236 mL in 1 TUBE; Type 0: Not a Combination Product 06/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/11/2018 Labeler - Hamilton Therapeutics, Inc. (099419360)
