Hydrocortisone Cream
FDA Label NDC 85402-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medrock Pharmacy Llc for the product Hydrocortisone (NDC 85402-001). 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 other, active ingredients, purpose, indications:, warnings:, stop use and ask a physician:, otc - keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

Active Ingredients

Hydrocortisone 1%

Purpose

Anti-itch, Topical Analgesic

Indications:

Helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin and lips and offers temporary relief of minor skinirritations and inflammation due to 

  • Weather
  • Allergies
  • Cold sores
  • Eczema
  • Cosmetics

    • Other uses of this product should only be under the advice or supervision of a doctor.

Warnings:

  • for external use only
  • Avoid contact with eyes  

Stop Use And Ask A Physician:

  • if condition worsens or symptoms persist for 7 days or clears up and occurs again within a few days, discontinue use of this product and consult a physician

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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 physician

For External Anal Itching:

  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

    • Children under 12 years of age: consult a doctor

Inactive Ingredients:

• Ricinus Communis (Castor) Seed Oil • Beeswax • Helianthus Annuus (Sunflower) Seed Oil • Prunus Amygdalus Dulcis (Sweet Almond) Oil
• Theobroma Cacao (Cocoa) Seed Butter • Butyrospermum Parkii (Shea) Butter • Simmondsia Chinensis (Jojoba) Seed Oil
• Tocopheryl Acetate

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