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 Kareway Product, 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
Anti-itch
Uses
temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:
- eczema
- insect bites
- poison ivy, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- temporarily relieves external anal and genital itching
- other uses of this product should only be 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. Consult a doctor.
- for the treatment of diaper rash. Ask a doctor
When Using This Product
- avoid contact with eyes
- do not use more than directed unless told to do so by a doctor
- do not put directly 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, and do not begin us of any other hydrocortisone product unless you have asked a doctor
- rectal bleeding occurs
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
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: Ask a doctor
- for external anal and genital itching, adults:
- when practical, clean the affected area with mild soap and 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
Other Information
- store at 20 to 25 oC (68 to 77 oF)
- see end of carton or tube crimp for lot number and expiration date
Inactive Ingredient
Cortizone-1 Hydrocortisone w/ Aloe aloe vera gel, beeswax, Cetyl alcohol, Dextrin, Glycerin, Light Mineral Oil, Maltodextrin, Methylparaben, Petrolatum, Propylparaben, Sodium cetyl sulfate, Sodium lauryl sulfate, and Purified water
Package Label.Principal Display Panel
Hydrocortisone
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