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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. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - WHEN USING
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. FOR EXTERNAL ANAL ITCHING:
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. PRINCIPAL DISPLAY PANEL - 28.4 G TUBE CARTON

Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320


Active Ingredient



Hydrocortisone 0.5%


Purpose



Anti-itch cream


Uses



  • •temporary relief of itching associated with minor skin irritations and rashes due to
    • •eczema
    • •insect bites
    • •poison ivy, poison oak, or poison sumac
    • •soaps
    • •detergents
    • •cosmetics
    • •jewelry
    • •seborrheic dermatitis
    • •psoriasis
    • •external genital 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
  • •by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask A Doctor Before Use If You Have



  • •a vaginal discharge
  • •rectal bleeding
  • •diaper rash

Otc - When Using



When using this product consult a doctor before exceeding recommended dosage


Stop Use And Ask A Doctor If



  • •condition gets worse
  • •condition persists for more than 7 days
  • •condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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.


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: do not use. consult a doctor


For External Anal Itching:



  • •Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • •gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

    • Children under 12 years of age: consult a doctor


Other Information



  • •To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • •store at room temperature
  • •see carton or tube crimp for lot number and expiration date

Inactive Ingredients



aloe barbadensis, cetostearyl alcohol, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol


Questions?



Call 1-866-923-4914


Principal Display Panel - 28.4 G Tube Carton



Itch and Rash Relief

Sensitive Skin

Hydrocortisone ½%
Cream
Antipruritic (Anti-Itch)

With Aloe

NET WT 1 oz (28.4 g)

63187-575-01 - hydrocortisone 01

63187-575-01 - hydrocortisone 01


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