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 Morales Distributors 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 1.0 percent
Purpose
Anti-Itch
Uses
temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to
- eczema
- psoriasis
- seborrheic dermatitis
- poison ivy, oak, sumac
- insect bites
- soaps and detergents
- cosmetics
- jewerly
- external feminine and anal itching Other uses of this product: ask a doctor
Warnings
For external use only
Do Not Use
- in or near the eyes
- by putting directly into the rectum by using fingers or any mechanical device or applicator
- for external feminine itching if you have a vaginal discharge
- for diaper rash; ask a doctor
Ask A Doctor Or Pharmacist
before use if you are using any other hydrocortisone product
When Using This Product
for external anal itching, do not exceed recommended daily dosage unless directed by a doctor
Stop Use And Ask A Doctor If
- condition worsens or does not improve within 7 days
- symptoms clear up and return within a few days
- 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 Ingredients
butylated hydroxytoluene, cetyl alcohol, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, propylparaben, purified water, squalane, and stearic acid
Principal Label
NDC NO. 53210-1002-0
Compare to maximum strength Cortaid(R) active ingredient
Maximum Strength
FAST RELIEF
plus itching plus redness
Anti-Itch Cream for Skin Irritations
Relieves Itching and Redness Fast
Hydrocortisone 1 percent Cream
NET 1oz(28.3g)
Exclusively distributed by:
Morales Distributors, Inc
Mayaguez, P.R. 00682
This product is not manufactured or distributed by Pharmacia Consumer Healthcare, owner of the registered trademark Cortaid.(R)
Made in Korea
* Please review the disclaimer below.