Active Ingredient
Hydrocortisone Acetate
Hydrocortisone Ointment
FDA Label NDC 70000-0489
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Hydrocortisone (NDC 70000-0489). 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, if pregnant or breast-feeding,, do not use, stop use and ask a doctor if, otc - 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
Antipruritic (Anti-Itch)
Uses
For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumak, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine and anal itching
Warnings
For external use only
If Pregnant Or Breast-Feeding,
ask a health professional before use
Do Not Use
- in the eyes
- for diaper rash
- for external genital or feminine itching if you have a vaginal discharge
- more than the recommended daily dosage unless directed by a doctor
- this product in the rectum by using finger or any mechanical device
Stop Use And Ask A Doctor If
condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer than 7 days, or if bleeding occurs near anus when used for anal itching
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a poison control center (1-800-222-1222) 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: consult a doctor.
- When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching.
Other Information
- Store at room temperature
- Avoid excessive heat
Inactive Ingredients
Liquid Paraffin, Sorbitan Sesquioleate, White Soft Paraffin
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