FDA Label for Hydrocortisone Maximum Strength
View Indications, Usage & Precautions
Hydrocortisone Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Aru Pharma 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.
Drug Facts
Active Ingredient
Hydrocortisone USP 1%
Purpose
Anti-itch
Uses
• for temporary relief of itching associated with minor skin irritations and rashes due to: • Eczema • Insect bites • Soaps and detergents • Cosmetics • Jewelry • Seborrheic dermatitis • Psoriasis • Poison ivy, oak or sumac • For external genital, feminine and anal itching • Other uses of this product should be only under the advice and supervision of a doctor
Warnings
For external use only
Do not use • In children under 2 years of age • If you have a vaginal discharge • For the treatment of diaper rash
Ask a doctor before use if you have • External genital or feminine itching • External anal itching • Bleeding
When using this product • Avoid contact with eyes • Do not exceed the recommended daily dosage unless directed by a doctor • Do not put this product into the rectum by 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, stop use and do not begin use of any other hydrocortisone product, unless you have consulted a doctor.
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. (1-800-222-1222)
Directions
For minor skin irritations and rashes, adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. For external anal itching: • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product • Children: under 12 years of age, consult a doctor.
Inactive Ingredients
Cetostearyl Alcohol, Cetomacrogol 1000, Paraffin Wax, Micro Crystalline Wax, Propylene Glycol, Light Liquid Paraffin, Mono basic Sodium Phosphate, Propyl Paraben, Methyl Paraben, Chlorocresol, Purified Water
Other Information
• Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
• store at room temperature • See crimp of tube or carton for Lot Number and Expiration Date
Questions Or Comments?
1 844 500-2729 between 9 am and 4 pm EST, Monday to Friday.
Packaging
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