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  5. Label Information: Hydrocortisone

FDA Label for Hydrocortisone

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF THE REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. INACTIVE INGREDIENT
    8. OTHER INFORMATION
    9. OTHER
    10. PACKAGING

Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceuticals Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Hydrocortisone 1%


Purpose



Anti-itch


Keep Out Of The Reach Of Children



If swallowed, get medical help or contact a Poison Control Center immediately.


Uses



temporary 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.


Warnings



● for external use only ●avoid contact with the eyes

●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 ● 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.

    For External Anal Itching Users: ● do not exceed the recommended daily dosage unless directed by a doctor
    ● in case of bleeding, consult a doctor promptly
    ● do not put this product into the rectum by using fingers or any mechanical device or applicator
    ● children under 12 years of age: consult a doctor

    Before using any medication, read all label directions. Keep this carton. It contains important information.


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 Ingredient



Inactive ingredients Light Mineral Oil, White Petrolatum


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 for lot number and expiration date.


Other



Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA
1-888-296-9067


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