Active Ingredient
Hydrocortisone 1%
Hydrocortisone Cream
FDA Label NDC 69396-147
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 for the product Hydrocortisone Cream (NDC 69396-147). 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, keep out of reach of children, warnings, directions, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Itch
Uses
Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- seborrheic dermatitis
- psoriasis
- insect bites
- poison ivy
- poison oak
- poison 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
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
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
- 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.
Children under 2 years of age
For external and anal ithcing
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
When Using This Product
- avoid contact with the 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 fingersor any mechanical device or applicator.
Stop Using This Product And Ask A Doctor If
- Conditions 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 of any other hydrocortisone product unless directed by a doctor.
Questions
Call 1-800-883-0085
Inactive Ingredients
Cetyl alcohol, Edetate disodium, methylparaben, mineral oil, mono-and-di-glycerides, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate.
Other Information
Store at controlled room temperature 20°C - 25°C (68°F - 77°F).
Proudly Distributed By:
Associated Wholesale Grocers, Inc.
Kansas City, Kansas 66106
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