Otc - Active Ingredient
Active ingredient Purpose
Hydrocortisone
1%....................................................................Anti-itch
Shopko Hydrocortisone With Aloe
FDA Label NDC 65923-699
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 With Aloe (NDC 65923-699). 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, warnings, otc - stop use, otc - do not use, otc - keep out of reach of children, indications & usage, storage and handling, 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 dermatitis
- psoriasis
- insect bites
- poison ivy, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- external genital, feminine and anal itching. Other uses of this product should be 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 - Do Not Use
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
Storage And Handling
Other information
- store at room temperature
- Lot No. and Exp. Date: see box or see crimp of tube
Inactive Ingredient
Inactive ingredients
Aloe Vera Gel, Butylated Hydroxytoluene, Cetanol, Liquid Paraffin, Methylparaben, Polyonyethylene Cetylether, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Monostearate, Stearyl Alcohol
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 (Shopkohydroaloe)
* Please review the disclaimer below.
