Active Ingredient
Hydrocortisone USP 1%
Hydrocortisone Cream
FDA Label NDC 0404-0166
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein for the product Hydrocortisone (NDC 0404-0166). 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 active ingredient, purpose, use(s), warnings, do not use, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 within a few days. Do not continue to use this or any other hydrocortisone product for longer that 7 days
• In case of bleeding when used for 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 using for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with bathroom tissue or soft cloth befor 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 seal is damaged.
Inactive Ingredients
Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum
Questions?
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Label
Hydrocortisone Cream 1%
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