Warnings
Avoid contact with open wounds, eyes or mucus membrains. If excessive skin irritation develops. Wash with water and discontinue use.
Consult a doctor if injuries are severe.
Arnica Ice Cooling
FDA Label NDC 70674-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kyron Laboratories (pty) Ltd for the product Arnica Ice Cooling (NDC 70674-001). 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 warnings, otc - purpose, otc - active ingredient, inactive ingredient, otc - keep out of reach of children, dosage & administration, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Muscular relief cooling gel
Otc - Active Ingredient
ARNICA OIL
CAMPHOR
WITCH HAZEL
MENTHOL CRYSTALS
Inactive Ingredient
CARBOPOL 990
WATER
POLYSORBATE 80
METHYL HYDROXYBENZOATE
PROPYL HYDROXYBENZOATE
TRIETHANOLAMINE 85%
Otc - Keep Out Of Reach Of Children
Keep out of reach of children, animals and uniformed persons.
Although this remedy has been extensively tested under a wide variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek advice and notify the registration holder.
This medicine has not been evaluated by the MCC.
This medicine is not intended to diagnose, treat, cure or prevent any disease.
Dosage & Administration
Use only as directed
Indications & Usage
indications and usage
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
