Otc - Active Ingredient
Hydrocortisone 1%
Rite Aid Cortisone Spray
FDA Label NDC 11822-0113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Rite Aid Cortisone (NDC 11822-0113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-itch
Indications & Usage
For the temporary relief of itching associated with minor skin irritation and rashes due to eczema, poison ivy, oak, and sumac, cosmetics, jewelry, soaps and detergents, and insect bites. Other uses of this product should be only under the advice and supervision of a doctor.
Warnings
For external use only. Flammable--Keep away from fire or flame. Do not use for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor. To apply to face, spray into palm of hand and gently apply.
Inactive Ingredient
Alcohol Denat., Dimethyl Isosorbide, Glycerin, Water
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