FDA Label for Hydrocortisone 1%
View Indications, Usage & Precautions
Hydrocortisone 1% Product Label
The following document was submitted to the FDA by the labeler of this product Ezricare Llc. 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.
Drug Facts
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 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 or applicator
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
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 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
• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature
• Avoid excessive heat • See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients
Mineral Oil, Sorbitan Sesquioleate, White Petrolatum
Questions Or Comments?
718-502-6610 between 9 am to 4 pm EST, Monday-Friday.
Packaging
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