Otc - Active Ingredient
Calendula Officinalis 1X HPUS -2%
Korium
FDA Label NDC 70811-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gr8bio Llc for the product Korium (NDC 70811-001). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Healing Agent
Indications & Usage
May help promote healing of minor cuts, scratches and chafing.
Warnings
FOR EXTERNAL USE ONLY
Otc - Do Not Use
DO NOT USE if you are allergic to Calendula officinalis or to any of this product's inactive ingredients.
Otc - When Using
WHEN USING THIS PRODUCT:
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
You may experience some transient mild pain on the wound area.
Otc - Stop Use
STOP USE AND ASK DOCTOR IF YOU:
Have any allergic reaction to this product.
Experience a deep or puncture wound, animal bite, or serious burn.
Otc - Keep Out Of Reach Of Children
KWEEP OUT OF REACH OF CHILDREN. If swallowed get medical help or contact a poison control center right away.
Dosage & Administration
DIRECTIONS
- clean affected area thoroughly before applying
- apply spray twice a day (every 12 hours) on affected area until entirely covered.
- let dry and cover with a sterile bandage to promote healing.
- continue use as needed
Other Safety Information
OTHER INFORMATION
Store at room temperature 68-77°F (20-25°C).
Do not use if tamper evident seal is broken.
Inactive Ingredient
Butylated Hydroxytoluene
Ethanol
Polyethylene Glycol
Purified Water
* Please review the disclaimer below.
