Active Ingredient
Hydrocortisone 1.0%
Hydrocortisone
FDA Label NDC 76413-311
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Hydrocortisone (NDC 76413-311). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Principal Display Panel (28 g Tube Label)
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