FDA Label for Leader Hydrocortisone With Aloe

View Indications, Usage & Precautions

Leader Hydrocortisone With Aloe Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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%....................................................................Anti-itch


Otc - Purpose



Uses

for the temporary relief of itching associated with minor skin irriations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external genital, feminine and anal itching.
  • Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor


Warnings



Warnings

  • for external use only
  • avoid contact with eyes

Otc - Stop Use



Stop using this product 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
  • before you begin using any other hydrocortisone product

Otc - Do Not Use



Do not use this product and ask a doctor

  • if you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age

Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Before using any medication, read all label directions.  Keep this carton.  It contains important information.


Indications & Usage



Directions

  • for 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 users

    • adults: when practical, cleanse affected area with mild soap and warm water and rinse thorughly; gently dry by patting or blotting with toilet
    • tissure or a soft cloth before application of this product.

      • children under 12 years of age: cosult a doctor

Storage And Handling



Other information

  • store at room temperature
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient



Inactive ingredients

aloe vera gel, butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cethylether, propylene glycol, propylparaben,

purified water, psorbitan monostearate, stearyl alcohol


Dosage & Administration



DISTRIBUTED BY

CARDINAL HEALTH, DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in Korea


Package Label.Principal Display Panel




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