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ECZEMA THERAPY by KATE SOMERVILLE SKINCARE, LLC

Medically reviewed on June 25, 2018

Dosage form: cream
Ingredients: OATMEAL 1g in 100mL
Labeler: KATE SOMERVILLE SKINCARE, LLC
NDC Code: 43479-301

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.

ACTIVE INGREDIENTS

COLLOIDAL OATMEAL 1%

PURPOSE

SKIN PROTECTANT

USES

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN RRITATION AND ITCHING DUE TO:

  • ECZEMA
  • RASHES

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

  • DO NOT GET INTO EYES.

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.

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

  • APPLY AS NEEDED

OTHER INFORMATION
  • FOR USE ON MILD TO MODERATE ECZEMA OR AS DIRECTED BY A PHYSICIAN. STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Petrolatum, Glycerin, Caprylyl Caprylate/Caprate, Stearyl Alcohol, Polyglyceryl-2 Stearate, Glyceryl Stearate, Meadowfoam Estolide, Dimethicone, Ethyl Linoleate. Squalane, Ribes Nigrum (Black Current) Seed Oil, Undaria Pinnatifida Extract, Centipeda Cunninghamii Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sea Whip Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract. Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Xanthan Gum, Butylene Glycol, Ethylhexylglycerin, Octyldodecanol, Cetyl Alcohol, Arachidyl Alcohol, Disodium EDTA, Phenoxyethanol

ECZEMA THERAPY 
oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43479-301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (OATMEAL) OATMEAL1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MEDIUM-CHAIN TRIGLYCERIDES 
PETROLATUM 
GLYCERIN 
CAPRYLYL CAPRYLATE/CAPRATE 
STEARYL ALCOHOL 
POLYGLYCERYL-2 MONOISOSTEARATE 
GLYCERYL MONOSTEARATE 
MEADOWFOAM SEED OIL FATTY ACIDS 
DIMETHICONE 
ETHYL LINOLEATE 
SQUALANE 
RIBES NIGRUM SEED OIL 
UNDARIA PINNATIFIDA 
CENTIPEDA MINIMA WHOLE 
SUNFLOWER OIL 
PSEUDOPTEROGORGIA ELISABETHAE 
CARDIOSPERMUM HALICACABUM WHOLE 
TOCOPHEROL 
ROSEMARY 
XANTHAN GUM 
BUTYLENE GLYCOL 
ETHYLHEXYLGLYCERIN 
OCTYLDODECANOL 
CETYL ALCOHOL 
ARACHIDYL ALCOHOL 
EDETATE DISODIUM 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:43479-301-541 TUBE in 1 BOX
1NDC:43479-301-14120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/18/2014
Labeler - KATE SOMERVILLE SKINCARE, LLC (615155533)

 
KATE SOMERVILLE SKINCARE, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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