Active Ingredient
Hydrocortisone 1%
Procure Hydrocortisone 1% Cream
FDA Label NDC 55681-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Twin Med Llc for the product Procure Hydrocortisone 1% (NDC 55681-019). 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, otc - purpose, uses, warnings, do not use, stop use and ask a doctor if, when using this product, 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
Otc - Purpose
Anti-Itch
Uses
- For the temporary relief of itchng associtated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soaps
- Other uses of this product should be onl under the advise and supervision of a doctor
Warnings
Warnings
for external use only.
Do Not Use
Do not use for the treatment of diaper rash. Consult a doctor
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
When Using This Product
When using this product
- avoid contact with eyes
- do not begin use of any other hydrocortisone product unless you have consulted a doctor
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.
Directions
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: do not use, consult a doctor
Inactive Ingredients
Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum
* Please review the disclaimer below.
