Eczema Therapy (Colloidal Oatmeal) Cream [Hamilton Therapeutics, Inc.] -

ECZEMA THERAPY (COLLOIDAL OATMEAL) CREAM [HAMILTON THERAPEUTICS, INC.]
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NDC	72381-103-01
Set ID	6e61ba86-3359-c099-e053-2a91aa0a1484
Category	HUMAN OTC DRUG LABEL
Packager	Hamilton Therapeutics, Inc.
Generic Name
Product Class
Product Number
Application Number	PART347

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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

INGREDIENTS AND APPEARANCE

ECZEMA THERAPY
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72381-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72381-103-01	236 mL in 1 TUBE; Type 0: Not a Combination Product	06/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/11/2018

Labeler - Hamilton Therapeutics, Inc. (099419360)

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Medic

ECZEMA THERAPY (COLLOIDAL OATMEAL) CREAM [HAMILTON THERAPEUTICS, INC.]

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