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 Dynarex Corporation. 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 Acetate 1%
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 sumac, 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 yes
- 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 rectumby using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product.
- in case of bleeding when used for anal itching
Otc - 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 of age and older: Apply to affected area not more than 3 to 4 time 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
Ceteareth-20, Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Mineral Oil, Propylene Glycol, Sodium Metabisulfite, Water, White Petrolatum
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