Hydrocortisone
FDA Label NDC 50382-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galentic Pharma (india) Priva Te Limited for the product Hydrocortisone (NDC 50382-010). 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, purpose:, warnings:, 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)

Purpose:

For temporary relief of;

  • minor skin irritations

    • Itching 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

Warnings:

For external use only

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 the recommended daily dosage unless directed by a doctor
  • in the rectum bu using fingers or any other mechanical device or applicator

Stop Use And Ask A Physician If:

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

Keep Out Of Reach Of Children

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

Directions:

Adults and children over 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

Other Information:

  • Store at 20 deg - 25 deg C (68 deg - 77 deg F)
  • Avoid excessive heat and humidity

Inactive Ingredients:

Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Sodium Betabisulphite, White Soft Paraffin, Water (purified)

Indications & Usage

For temporary relief of minor skin irritations and external itching.

Principal Display Panel

Hydrocortisone 1%

Hydrocortisone Cream.jpg

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