Active Ingredient
Hydrocortisone 1%
Hydrocortisone Cream
FDA Label NDC 69396-028
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 69396-028). 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, stop using this product and ask a doctor, do not use this product and ask a doctor, directions, 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, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- external 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
- avoid contact with eyes
- do not put this product into the rectum by using fingers or any mechanical device or applicator
- do not exceed the recommended daily dosage unless directed by a doctor
- in case of bleeding, consult a doctor promptly
- children under 12 years of age: consult a doctor
For External Anal Itching Users:
Before using any medication, read all label directions. Keep this carton as it contains important information
Stop Using This Product And Ask A Doctor
- in case of bleeding
- if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
- before you begin using any other hydrocortisone product
Do Not Use This Product And Ask A Doctor
- If you have a vaginal discharge
- before treating diaper rash
- before using on children under 2 years of age
Directions
- When practical, cleanse the 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
- adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily
- children under 12 years of age: do not use, consult a doctor
Inactive Ingredients
Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecannol, petrolatum, purified water, sodium dodecyl sulfate
Other Information
- to open; unscrew cap and pull tab to remove foil seal
- if seal has been broken, do not use this product. Return product to the store where you bought it
- store at controlled room temperature 15°-30°C (59°-86°F)
- see carton or tube crimp for lot number and expiration date
Distributed By:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
Product of PRC
www.trifecta-pharma.com
1-888-296-9067
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