FDA Label for Hydrocortisone
View Indications, Usage & Precautions
Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Padagis Israel Pharmaceuticals Ltd. 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.
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-itch
Uses
• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:• eczema• psoriasis• poison ivy, oak, sumac• insect bites• detergents• jewelry• seborrheic dermatitis• soaps• 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
• for the treatment of diaper rash. Ask a doctor.• for external genital itching if you have a vaginal discharge. Ask a doctor.
When Using This Product
• avoid contact with the eyes• do not begin use of any other hydrocortisone product unless you have asked a doctor• for external anal itching 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 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
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• do not use. Ask a doctor.• 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 with external anal itching: ask a doctor
children under 2 years of age:
for external anal itching:
Other Information
• store at 20°-25°C (68°-77°F)
Inactive Ingredients
aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water
Questions Or Comments?
1-800-719-9260
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Relieves Itching and Redness Fast
Maximum Strength
Helps Heal Rashes for Healthier Skin
Compare to Cortaid® active ingredient
Hydrocortisone Cream 1%
Maximum Strength Anti-Itch Cream
NET WT 1 OZ (28 g)
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