Hydrocortisone
FDA Label NDC 45865-906
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medsource Pharmaceuticals for the product Hydrocortisone (NDC 45865-906). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Hydrocortisone, USP 1%
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 sumac
- soaps
- jewelry
- detergents
- cosmetics
- psoriasis
- seborrheic dermatitis
- for external genital, feminine 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 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 A 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.
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
- do not use, consult a doctor
Children under 2 years of age
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
Children under 12 years of age: consult a doctor
Other Information
- Store at room temperature 59°-86°F (15°-30°C).
- Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients
mineral oil, white petrolatum
Questions?
1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.
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Pdp (906)
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