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  5. Label Information: Hydrocortisone Acetate

FDA Label for Hydrocortisone Acetate

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. PURPOSE
    3. WARNINGS:
    4. INDICATIONS AND USAGE:
    5. STOP USE AND ASK A PHYSICIAN IF:
    6. KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE AND ADMINISTRATION:
    8. OTHER INFORMATION:
    9. INACTIVE INGREDIENTS:
    10. PRINCIPAL DISPLAY PANEL

Hydrocortisone Acetate Product Label

The following document was submitted to the FDA by the labeler of this product Galentic Pharma (india) Private Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)


Purpose



Hydrocortisone is 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


Indications And Usage:



  • 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
  • For temporary relief of minor skin irritations and external itching.

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.

Dosage And Administration:



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:



Liquid Paraffin, White Soft Paraffin


Principal Display Panel



Hydrocortisone

Gal Hydro Ointment.jpg


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