Hydrocortisone Ointment
FDA Label NDC 69396-003

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 (NDC 69396-003). 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, keep out of the reach of children, uses, warnings, directions, inactive ingredient, other information, 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

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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