Hydrocortisone 1% Cream
FDA Label NDC 69396-118
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 69396-118). 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, do not use, 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
Antipruritic (Anti-Itch)
Uses
For temporary relief of itching associated with minor skin irritations and rashes
● external feminine, genital and anal itching
Other uses of this product should be only under the advice and supervision of a doctor
Do Not Use
- For the treatment of diaper rash, consult a doctor.
- With any other Hydrocortisone product unless you have consulted a doctor
- If you have a vaginal discharge, consult a doctor
Warnings
For external use only
When Using This Product
- Avoid Contact with the eyes
- do not exceed the recommended daily dosage unless directed by a doctor.
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Using This Product And Ask A Doctor If
- conditions worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product.
- Rectal bleeding occurs
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 and ask a doctor.
For External and anal itching in adults:
When practical, clean affected area with mild soap and warm water and rinse thoroughly
Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
For External anal and genital itching in children under 12 years of age:
Ask a doctor
Inactive Ingredients
Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water.
Other Information
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
Tamper evident, do not use if packet is torn, cut or opened.
Avoid excessive heat and humidity.
Other
Distributed by:
Trifecta Pharmaceuticals USA™
Ft. Lauderdale, FL 33301 USA
Online: www.trifecta-pharma.com
Reorder No. 1016SL
To reorder call: 1-888-296-9067
Fax: 888-878-3609
Questions
Call 1-888-296-9067
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