Active Ingredient
Hydrocortisone 1%
Hydrocortisone Ointment
FDA Label NDC 69396-149
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Hydrocortisone (NDC 69396-149). 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, keep out of the reach of children, uses, warnings, directions, inactive ingredient, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Uses
temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps
●detergents ● cosmetics ● jewelry ●external feminine genital and anal itching
other uses of this product should be only under the advice and supervision of a doctor.
Warnings
● for external use only
Directions
Adults and children 2 years 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 and anal itching:
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
Children under 12 years of age with external anal itching: consult a doctor.
Inactive Ingredient
Inactive ingredients Light Mineral Oil, Petrolatum
Do Not Use
Do Not use
- For the treatment of diaper rash, consult a doctor
- for external genital itching if you have a vaginal discharge, consult a doctor.
Other Information
- store at controlled room temperature 20°-25°C (68°- 77°F)
Distributed By
Proudly Distributed By:
Associated Wholesale Grocers Inc.
Kansas City, Kansas 66106
Stop Using This Product And Ask A Doctor If
- Conidtions worsen
- Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use any other hydrocortisone product unless directed by a doctor.
When Using This Product
- Avoid contact with eyes
- Do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
- For external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor.
- In case of bleeding, stop use, consult a doctor.
- Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Questions:
Call 1-800-883-0085
* Please review the disclaimer below.
