FDA Label for Leader Hydrocortisone
View Indications, Usage & Precautions
Leader Hydrocortisone 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
- do not exceed the recommended daily dosage unless directed by a doctor
- in case of bleeding, consult a doctor promptly
- do not put this product into rectum by using fingers or any mechanical device or applicator
For external anal itching users:
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
- adults: when practical, cleanse affected area with mild soap and warm water and rinse thoroughly; gently dry by patting or blotting with toilet
- children under 12 years of age: consult a doctor
For external anal itching users
or a soft cloth before application of this product
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
butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol
Dosage & Administration
DISTRIBUTED BY
CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Package Label.Principal Display Panel
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