Active Ingredient
Hydrocortisone 1%
Dermfree Anti-itch Cream
FDA Label NDC 87686-001
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 Zhongletang Pharmaceuticals Co.,ltd. for the product Dermfree Anti-itch Cream (NDC 87686-001). 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, when using, stop use, ask doctor, 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 pain and itching associated with:▇insect bites▇ minor burns ▇sunburn▇ minor skin irritations▇ minor cuts ▇scrapes▇ rashes due to poison ivy, poison oak, and poison sumac ▇dries the oozing and weeping of poison ivy, poison oak ，and poison sumac
Warnings
For external use only.
Do Not Use
▇on large areas of the body
▇with any other product containing diphenhydramine, even one taken by mouth
When Using
avoid contact with eyes
Stop Use
▇condition worsens or does not improve within 15 days
▇symptoms persist for more than 15 days or clear up and occur again within a few days
Ask Doctor
▇condition worsens or does not improve within 15 days
▇symptoms persist for more than 15 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
▇do not use more than directed
▇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
▇protect from excessive heat (40°C/104°F)
Inactive Ingredients
Purified Water, Polysorbate 80, Phenoxyethanol, C18‑16 Alcohol, Glyceryl Stearate, Stearic Acid, Liquid Paraffin, 95%(v/v) Ethanol
Principal Display Panel
1 (C22360ea96f4c1133094dafae6d1a60c)
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