FDA Label for Hydrocortisone Cream With Aloe
View Indications, Usage & Precautions
Hydrocortisone Cream With Aloe Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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
For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- seborrheic dermatitis
- psoriasis
- insect bites
- poison ivy, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- external feminine, genital and anal itching
Other uses of this product should be only under the advice and supervision of a doctor.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Warnings
- for external use only
- avoid contact with eyes
- do not put this product into the rectum by using fingers or any mechanical device or applicator
- do not exceed the recommended daily dosage unless directed by a doctor
- in case of bleeding, consult a doctor promptly
- children under 12 years of age: consult a doctor
For External Anal Itching Users:
Before using any medication, read all label directions. Keep this carton as it contains important information
Do Not Use
- For the treatment of diaper rash, consult a doctor
- For the external genital itching if you have a vaginal discharge, consult a doctor
Stop Using This Product And Ask A Doctor If
- Conditions worsen
- 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 directed by a doctor.
When Using This Product
- avoid contact with the eyes.
- do not begin the use of any other hydrocortisone product unless you have consulted a doctor
- for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
Directions
Adults and children 2 years and older
- apply to affected area not more than 3 to 4 times daily.
- Do not use, consult a doctor
- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily
- children under 12 years of age with external anal itching: consult a doctor.
Children under 2 years of age
For External and anal itching
by patting or blotting with toilet tissue or a soft cloth before application of this product.
Inactive Ingredients
Aloe barbadensis leaf juice, Cetyl alcohol, Edetate Disodium, Methylparaben, Mineral Oil, Mono and di glycerides, petrolatum, Polysorbate 60, Propylene glycol, propylparaben, purified water, sorbitan monostearate.
Other Information
- store at controlled room temperature 20°-25°C (68°-77°F)
Distributed By:
Rugby Laboratories®
Indianapolis, IN 46268
www.majorpharmaceuticals.com
1-800-616-2471
This product is not manufactured or distributed by Chattem, Inc. owner of the registered trademark Cortizone 10®
* Please review the disclaimer below.