Hydrocortisone
FDA Label NDC 67777-415

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 67777-415). 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

For temporary relief of:

  • minor skin irritations

    • Itches and rashes due to:

    • eczema
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry

      • and for external itching of:

      • 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 physician if:

  • the condition persists or gets worse
  • symptoms clear up and appear again within a few days
  • you are pregnant or breast feeding

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:

  • apply evenly to affected area no more than 3 or 4 times daily.

    • Children under 2 years of age:

    • Do not use
    • consult a physician

      • Adults:

      • when practical, 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
      • apply externally to the area up to 6 times daily or after each bowel movement

        • ​

Inactive Ingredient

Inactive ingredients:

Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, edetate disodium, liquid paraffin, propylene glycol, sodium betabisulphate, white soft paraffin, water (purified)

Other

Other information:

  • store at 20 deg. to 25 deg. C (68 deg. - 77 deg. F)
  • avoid excessive heat and humidity

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

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