FDA Label for Hydrocortisone
View Indications, Usage & Precautions
Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Weeks & Leo Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-itch
Uses
For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- seborrheic dermatitis
- poison ivy, poison oak, and poison sumac
- psoriasis
- insect bites
- cosmetics
- jewelry
- detergents
- soaps
temporarily relieves external anal and genital itching
other uses of this product should be only under the advise and supervision of a doctor
Warnings
For external use only
Do Not Use
- for the treatment of diaper rash. Ask a doctor.
- for external genital itching if you have a vaginal discharge. Ask a doctor.
- for external anal itching if rectal bleeding occurs. Consult a doctor promptly.
When Using This Product
- do not get in the eyes
- for external anal itching, do not use more than directed unless told to do so by a doctor
- do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.
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 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:
- when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with an appropriate cleansing pad
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
for external anal itching in children under 12 years: ask a doctor
Other Information
- store at 20°C to 25°C (68°F to 77°F)
Inactive Ingredient
white petrolatum
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