Hydrocortisone
FDA Label NDC 67777-224

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Hydrocortisone (NDC 67777-224). 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 otc - active ingredient, warnings:, purpose, do not use:, stop use and ask a physician if:, keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

Warnings:

For external use only

Purpose

Use:

  • For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching.

Do Not Use:

  • in the eyes 
  • for diaper rash
  • for external genital or feminine itching if you have a vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • this product in the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Physician If:

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product.
  •  in case of bleeding when used for anal itching

Keep Out Of Reach Of Children

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching.

Other Information:

  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients:

Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Liquid Paraffin, Propylene Glycol, Purified water, White Soft Paraffin.

Indications & Usage

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching.

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