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  5. Label Information: Hydrocortisone

FDA Label for Hydrocortisone

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. USES:
    3. WARNINGS:
    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 AND 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 USP 10 mg            Antipruritic (anti-itch)


Uses:



For temporary relief of;
  • minor skin irritations, inflammation and rashes due to
    • eczema
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • scrapes

      • and for external itching of;
      •  genital
      • feminine and
      • anal itching

        • other uses of this product should be only under the advice and supervision of a doctor

Warnings:



For external use only


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

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.

Directions:



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 a controlled room temperature 15 deg - 30 deg C (59 deg - 86 deg F)
  • Avoid excessive heat and humidity
  • tamper evident, do not use if packet is torn, cut or open

Inactive Ingredients:



citric acid, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propyl paraben, propylene glycol, purified water, sodium citrate, titanium dioxide,


Indications And Usage



For temporary relief of minor skin irritations and external itching.


Package Label.Principal Display Panel



Principal Display

Hydrocortisone - Hydrocortisone

Hydrocortisone - Hydrocortisone



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