Hydrocortisone
FDA Label NDC 67510-0632

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Hydrocortisone (NDC 67510-0632). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:

  • eczema
  • insect bites
  • poison ivy, oak, sumac
  • soaps 
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only.

Directions

  • for itching of skin irritation, inflammation, and rashes:
  • 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: Ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: Ask a doctor

Other Information

  • store at 20 to 25 oC (68 to 77 oF)
  • see end of carton or tube crimp for lot number and expiration date

Inactive Ingredient

Cortizone-1 Hydrocortisone w/ Aloe aloe vera gel, beeswax, Cetyl alcohol, Dextrin, Glycerin, Light Mineral Oil, Maltodextrin,  Methylparaben, Petrolatum, Propylparaben, Sodium cetyl sulfate, Sodium lauryl sulfate, and Purified water

Package Label.Principal Display Panel

Hydrocortisone

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