FDA Label for Hydrocortisone Maximum Strength
View Indications, Usage & Precautions
Hydrocortisone Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. 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 USP, 1%
Purpose
Anti-itch
Use
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
- eczema
- psoriasis
- insect bites
- poison ivy, oak, sumac
- detergent
- jewelry
- cosmetics
- soaps seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should be only under the advise 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. Consult
When Using This Product
- avoid contact with the eyes
- do not use more than directed unless directed 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
- do not begin the use of any other hydrocortisone product unless directed by a doctor
- rectal bleeding occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Direction
- 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: consult a doctor
- for external anal and genital itching
- adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- apply to affected area not more than 3 to4 times daily
- children under 12 years of age: consult a doctor
Other Information
- store at 15°-30°C (59°-86°F). Protect from freezing.
- before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients
cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution*, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT IN MAXIMUM STRENGTH CORTIZONE 10®†
MAXIMUM STRENGTH
Hydrocortisone Cream USP, 1%
ANTI-ITCH CREAM
Relieves
Itches and Rashes
NET WT. OZ (g)
For the temporary relief of itching associated with minor skin irritations, inflammation and rashes
†This product is not manufactured or distributed by Chattem, Inc., distributor of Maximum Strength Cortizone 10®.
Distributed by:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
Package Label
PREMIER VALUE Maximum Strength Hydrocortisone Cream 1%
* Please review the disclaimer below.