Hydrocortisone
FDA Label NDC 67777-417

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 67777-417). 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, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, 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 1%                              Antipruritic (anti-itch)

Warnings

​For external use only

Purpose

Uses: For 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 external genital, feminine, and anal itching.

Otc - Do Not Use

Do Not Use:

  • in the eyes
  • longer than 1 week unless directed by a physician
  • for diaper rash
  • if you have vaginal discharge
  • more than recommended daily dosage unless directed by a doctor
  • in the rectum using fingers or any other mechanical device or applicator

Otc - Stop Use

Stop use and ask a doctor if:

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

Otc - 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.

Dosage & Administration

Directions:

Adults and children 2 years of age and older:

  • apply evenly to affected area no more than 3 or 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 and blotting with bathroom tissue or soft cloth before applying. Children under 12: consult doctor before using for anal itching.

      • ​

Inactive Ingredient

Inactive ingredients:

Cetostearyl alcohol, glyceryl monostearate, methylchloroisothiazolinone, propylene glycol, purified water, stearic acid, trolamine, white soft paraffin 

Other

Other information:

  • store at room temperature
  • avoid excessive heat

Indications & Usage

For temporary relief of minor skin irritations and external itching.

Package Label.Principal Display Panel

Principal Display Panel

Dynarex Hydrocortisone Items 1137 and 1139

Hydro 1139.jpg

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