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 Kareway Product, Inc.. 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
temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:
- eczema
- psoriasis
- seborrheic dermatitis
- poison ivy, oak, sumac
- insect bites
- soaps and detergents
- cosmetics
- jewelry
- external feminine and anal itching
- Other uses of this product: ask 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: Ask 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 finers 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
Directions
- apply to affected area not more than 3 to 4 times daily
- for external anal itching: when practical, clean 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
- children under 2 years, or children under 12 years with external anal itching: do not use, ask a doctor
Other Information
- store at room temperature, protect from freezing
Inactive Ingredient
Cetyl alcohol, Butylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myristoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water
Package Label.Principal Display Panel
Hydrocortisone
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