Hydrocortisone 1% Cream
FDA Label NDC 69396-055
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 1% (NDC 69396-055). 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, otc - keep out of reach of children, uses, warnings, when using this product, stop using this product 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 1%
Purpose
Anti-Itch
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Uses
For 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
Do not Use:
For the treatment of a diaper rash, consult with doctor
For external genital itching if you have a vaginal discharge, consult 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 and consult a doctor.
- do not put this product into the rectum by using fingers or any medicated 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.
Directions
Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 2 years of age: do not use, consult a doctor.
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 Ingredients
Ethylparaben, glycerin, glyceryll monostearate, mineral oil, stearyl alcohol, petrolatum, purified water, sodium lauryl sulfate
Other Information
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
Other
Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301 USA
Product of PRC
www.trifecta-pharma.com
This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone - 10®
* Please review the disclaimer below.
