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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. OTC - DO NOT USE
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. OTHER
    10. INDICATIONS & USAGE
    11. PACKAGE LABEL.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 1%                              Antipruritic (anti-itch)


Warnings



​For external use only


Purpose



Uses: For 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 external genital, feminine, and anal itching.


Otc - Do Not Use



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

Otc - Stop Use



Stop use and ask a doctor if:

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

Otc - 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.

Dosage & Administration



Directions:

Adults and children 2 years of age and older:

  • apply evenly to affected area no more than 3 or 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 and blotting with bathroom tissue or soft cloth before applying. Children under 12: consult doctor before using for anal itching.

      • ​


Inactive Ingredient



Inactive ingredients:

Cetostearyl alcohol, glyceryl monostearate, methylchloroisothiazolinone, propylene glycol, purified water, stearic acid, trolamine, white soft paraffin 


Other



Other information:

  • store at room temperature
  • avoid excessive heat

Indications & Usage



For temporary relief of minor skin irritations and external itching.


Package Label.Principal Display Panel



Principal Display Panel

Dynarex Hydrocortisone Items 1137 and 1139

Hydro 1139.jpg


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