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 Mericon Industries. 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.
Other
Drug Facts
For External Anal Itching Users
- adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- children under 12 years of age: consult a doctor
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-itch
Uses
For the temporary relief 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 genital and anal itching.
Other uses of this product should be only under the advice and supervision of a doctor.
Warnings
- For external use only
- avoid contact with the eyes
Stop Using This Product And Ask A Doctor
- if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
- before you begin using any other hydrocortisone product
Do Not Use This Product And Ask A Doctor
- if you have a vaginal discharge
- before treating diaper rash
- before using on children under 2 years of age
For External Anal Itching Users
- do not exceed the recommended daily dosage unless directed by a doctor
- in case of bleeding, consult a doctor promptly
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children
Directions
- 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: do not use, consult a doctor
Other Information
- store at 55 to 76F
Inactive Ingredients
stearic acid, propylene glycol, lanolin alcohol in mineral oil, isopropyl in myristate, cetyl alcohol, mono- and di-glycerides, polysorbate 80, sorbitan monooleate, a scent and purified water preserved with methylparaben and propylparaben.
Principal Display Panel - 114 G Bottle Label
0394-0859-32
Mericon Industries, Inc.
Hydrocortisone 1%
Lotion
Anti-Itch
Poison Ivy
Poison Oak
Poison Sumac
Hives • Rashes
Net Wt. 4 oz. (114g)
* Please review the disclaimer below.