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 Central Texas Community Health Centers. 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 1.0%
Purpose
Anti-itch
Uses
for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
- cosmetics
- soaps
- jewelry
- insect bites
- psoriasis
- eczema
- detergents
- seborrheic dermatitis
- external genital and anal itching
- poison ivy, poison oak, or poison sumac
Other uses of this product should be only under the advice and supervision of a doctor.
Do Not Use
- for the treatment of diaper rash. Consult a doctor.
- for external genital itching if you have vaginal discharge. Consult 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 use 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 immediately.
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. Consult a doctor.
- adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or 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: consult a doctor
Children under 2 years of age
For external anal itching
Other Information
- store at 15° to 30°C (59° to 86°F)
- lot number and expiration date: See crimp of tube or box
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
Inactive Ingredients
cetyl alcohol, diazolidinyl urea, isopropyl palmitate, mineral oil/lanolin alcohol, polysorbate 40, propylene glycol, propylene glycol monostearate, purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol, xanthan gum
Principal Display Panel - 28 G Tube Label
CommUnityCare Federally Qualified Health Centers
HYDROCORTISONE
1% CR 28g
Date:
Name:
Dr.
USE AS DIRECTED.
123456
1/1/01
HYDROCORTISONE 1% CRM 30G NDC 76413-311-30
Batch: 123456
Lot: 123456
Exp: 1/1/01
QUALITEST
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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