FDA Label for Advanced Hydrocortisone
View Indications, Usage & Precautions
Advanced Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Ultra Seal 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.
Otc - Active Ingredient
Active Ingredients (in each gram) Hydrocortisone USP-10 mg
Otc - Purpose
Purpose: Antipruritic (Anti Itch)
Indications & Usage
For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema,insect bites, poison ivy, poison oak, poison sumac, detergents, cosmetics, jewelry, saborrheic dermatitis, psoriasis and scrapes. For external feminine, genital, 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 for the treatment of diaper rash. Consult a doctor before use if :you have a vaginal discharge (for external feminine itching). For external itching, do not exceed the recommended daily dosage or if bleeding occurs. If condition worsens or symptoms persist more than 7 days or clear up and occur again within a few days.When using this product: Avoid contact with eyes, do not put this product into rectum using fingers or any mechanical device or applicatorDo not use with any other hydrocortisone product unless you have consulted a doctor
Dosage & Administration
Directions: For adults and children 2 years of age and older: Apply to affected area not more than 3-4 times dailyChildren under 2 years of age: Do not use, consult a doctor.Adults for external itching, when practical, cleanse the affected area with mild soap and warm water and rinse ththoroughly or by patting or blotting with an appropriate cleansing padGently dry by patting or blotting with toilet tissue or a soft cloth before application of this productChildren under 12 years of age-For external anal itching, consult a doctor
Inactive Ingredient
Inactive Ingredients: Citric Acid, Glycerin, Glycerol Stearate, Methylparaben, Petrolatum, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Titanium Dioxide
Package Label.Principal Display Panel
MM1
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
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