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  5. Label Information: Hydrocortisone

FDA Label for Hydrocortisone

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. WARNINGS:
    3. PURPOSE
    4. DO NOT USE:
    5. STOP USE AND ASK A PHYSICIAN IF:
    6. KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS:
    8. OTHER INFORMATION:
    9. INACTIVE INGREDIENTS:
    10. INDICATIONS & USAGE
    11. PRINCIPAL DISPLAY PANEL

Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Dynarex Corporation. 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)


Warnings:



For external use only


Purpose



Use:

  • For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching.

Do Not Use:



  • in the eyes 
  • for diaper rash
  • for external genital or feminine itching if you have a vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • this product in the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Physician If:



  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product.
  •  in case of bleeding when used for anal itching

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.

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 doctor.
  • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching.

Other Information:



  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients:



Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Liquid Paraffin, Propylene Glycol, Purified water, White Soft Paraffin.


Indications & Usage



For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching.


Principal Display Panel



1137 Hydro Cort.jpg


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