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  5. Label Information: Hydrocortisone

FDA Label for Hydrocortisone

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Nucare Pharmaceuticals,inc.. 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.

Other



Drug Facts

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117


Active Ingredient



Hydrocortisone, USP 1%


Purpose



Anti-itch


Uses



  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
    • eczema
    • psoriasis
    • insect bites
    • poison ivy, oak, sumac
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
    • temporarily relieves external anal and genital 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 genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

When Using This Product



  • avoid contact with the eyes
  • do not use more than directed unless directed by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If



  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
  • do not begin the use of any other hydrocortisone product unless directed by a doctor
  • rectal bleeding occurs

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



  • for itching of skin irritation, inflammation, and rashes
    • 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
    • for external anal and genital itching
      • adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly
      • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
      • apply to affected area not more than 3 to 4 times daily
      • children under 12 years of age: consult a doctor

Other Information



  • store at 15°-30°C (59°-86°F). Protect from freezing.
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients



cetyl alcohol, citric acid

Contains one or more of these ingredients to adjust pH

, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution , sorbic acid, sorbitan monostearate, stearyl alcohol, white wax


Questions Or Comments?



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