FDA Label for Hydrocortisone Cream 1%
View Indications, Usage & Precautions
Hydrocortisone Cream 1% Product Label
The following document was submitted to the FDA by the labeler of this product Front Line Safety. 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 USP 1%
Purpose
Antipruritic (Anti-Itch)
Use(S)
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, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching
Warnings
For External Use Only
If Pregnant Or Breastfeeding
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 • In 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 with a few days (do not continue to use this or any other hydrocortisone product for longer than 7 days)
• Bleeding occurs due to anal itching
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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
• Store at room temperature 15°-30°C (59°-86°F) • Avoid excessive heat • Tamper Evident. Do not use if packet is torn, cut or opened.
Inactive Ingredients
Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Petrolatum
Questions?
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Label
FL-2045
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