Active Ingredient
Hydrocortisone 1%
The following Structured Product Label (SPL) was submitted to the FDA by Weeks & Leo Co., Inc. for the product Hydrocortisone (NDC 11383-268). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Hydrocortisone 1%
Anti-itch
For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
temporarily relieves external anal and genital itching
other uses of this product should be only under the advise and supervision of a doctor
For external use only
If swallowed, get medical help or contact a Poison Control Center right away.
adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
children under 2 years: ask a doctor
for external anal itching in adults:
for external anal itching in children under 12 years: ask a doctor
white petrolatum
* Please review the disclaimer below.