Active Ingredient
Hydrocortisone, USP 1%
Hydrocortisone Cream
FDA Label NDC 80489-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ol Pharma Tech,llc for the product Hydrocortisone (NDC 80489-001). 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, uses, warnings, do not use, when using this product, stop use and ask your doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
Uses
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
•eczema
•insect bites
•poison ivy
•poison oak
•poison ...
Warnings
For external use only
Do Not Use
for external feminine itching if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.
When Using This Product
•avoid contact with the eyes
•do not begin the use of any other hydrocortisone product unless directed by a doctor
•for external anal itching:
do not use more than directed 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 Your Doctor If
•symptoms last for more than 7 days
•the condition gets worse
•symptoms clear up and occur again in a few days
•rectal bleeding occurs, consult doctor promptly
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.
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: do not use, consult a doctor
- For external anal itching
- Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Other Information
- Store at room temperature 59°-86°F (15°-30°C).
- Protect from freezing.
- Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients
cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil , propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E
Package Label.Principal Display Panel
original strenghth
fast itch relief cream
Hydrocortisone (Hydrocortisone)
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