Otc - Active Ingredient
Active Ingredient Purpose
Hydrocortisone 1% .................................................................................Anti-itch
Shopko Hydrocortisone
FDA Label NDC 55264-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Shopko Hydrocortisone (NDC 55264-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - when using, warnings, otc - stop use, otc - ask doctor, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- seborrheic dematitis
- psoriasis
- insect bites
- poison ivy, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- external genital, feminine and anal itching
Otc - When Using
Other uses or the use of this product for more than 7 days should be undertaken only under the advice and supervision of a doctor
Warnings
Warnings
- for external use only
- avoid contact with eyes
Otc - Stop Use
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
Otc - Ask Doctor
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
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Before using any medication, read all label directions. Keep this carton. It contains important information.
Indications & Usage
Directions
- for 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
Safe Handling Warning
Other information
- store at room temperature
- Lot No. and Exp. Date: see box or see crimp of tube
Inactive Ingredient
Inactive ingredients
glycerin, propylene glycol, sodium chloride, white petrolatum, cetyl alcohol, dimethicone, isopropyl palmitate, distearyldimonium chloride, methylparaben, propylparaben, purified water
Dosage & Administration
Distributed by:
United Exchange Corp.
17211 Valley View Ave.
Cerritos, CA 90703
www.ueccorp.com
Made in Korea
Package Label.Principal Display Panel
Image Of Carton Label (Shopkohydrocortisonecream)
* Please review the disclaimer below.
