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 Akron Pharma 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.
Active Ingredient
Hydrocortisone 1%
Purpose
Antipruritic (Anti-itch)
Use
temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- insect bites
- poison ivy or sumac
- soaps
- detergents
- cosmetics
- jewelry,
- seborrheic dermatitis
- poison oak
- psoriasis
- temporarily relieves external anal and genital itching
- Other uses of this product should be undertaken 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.
- for the treatment of diaper rash, Consult a doctor.
When Using This Product
- avoid contact with eyes
- do not use more thatn directed unless told to do so by a doctor
- do not put directly into the rectumby 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. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
- rectal bleeding occurs.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).
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: ask a doctor
- 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 applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
for external anal and genital itching, adults:
Other Information
• Store at 20-25 C (68-77 F).
Inactive Ingredients
aloe vera, benzyl alcohol, glyceryl monostearate, mineral oil, PEG-40, PEG-25, propylene glycol, purified water, squalane, stearic acid.
Questions Or Comments?
Call toll-free 1-877-225-6999
Other
Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
www.akronpharma.com
Made in USA
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