Active Ingredient
Hydrocortisone 1%
Drmitsui Eczema Relief Cream
FDA Label NDC 85248-181
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Drmitsui Eczema Relief (NDC 85248-181). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, stop use, ask doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
Use
·Temporarily relieves the itching and discomfort associated with minor skin irritations, rashes, and inflammation, and due to eczema.
·Other uses of this product should only be under the advice and supervision of a doctor.
Warnings
For external use only
Do Not Use
For the treatment of diaper rash. Consult a doctor.
Stop Use
condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
Ask Doctor
condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: ask a doctor.
Other Information
If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Cetyl Alcohol, Glycerin, Avena sativa (oat) kernel extract, Bisabolol, Glyceryl stearate, Isohexadecane, Magnesium ascorbyl phosphate, Maltodextrin, Borneol, Menthol.
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