ECZEMA THERAPY- colloidal oatmeal cream 
Hamilton Therapeutics, Inc.

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.

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Eczema Therapy

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

Uses

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

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

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

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

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.

Eczema Therapy

8 FL OZ/ 236mL

Eczema thera tube

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)

Revised: 2/2023
Document Id: f461455c-16d3-70b6-e053-2a95a90abb8e
Set id: 6e61ba86-3359-c099-e053-2a91aa0a1484
Version: 3
Effective Time: 20230210
 
Hamilton Therapeutics, Inc.