Active Ingredient(S)
Arnica montana1X HPUS
Velloryn Arnica Bruise Relief Cream
FDA Label NDC 84558-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yusong Fine Chemicls Co., Ltd for the product Velloryn Arnica Bruise Relief Cream (NDC 84558-015). 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 active ingredient(s), purpose, use, warnings, 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
Purpose
Relieves bruising and swelling
Use
Temporarily relieves symptoms associated with minor
bruises, including:·①swelling ②discoloration③tenderness
④minor soreness due to overexertion
Warnings
For external use only
Do Not Use
Do not use on broken or damaged skin, or if allergic to any ingredient.
Otc - When Using
·avoid contact with eyes and mucous membranes
·stop use if irritation occurs
Otc - Stop Use
. condition worsens ·symptoms persist for more than 7 days
. symptoms clear up and recur within a few days
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control
Center right away.
Directions
① apply a thin layer to the affected area 2 to 3 times daily
② massage gently until absorbed
③ wash hands after use
Other Information
store at 20°-25°C(68°-77°F)
protect from excessive heat and direct sunlight
Inactive Ingredients
Water, Glycerin, Propylene Glycol, Caprylic/Capric Triglyceride,
Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate,
Dimethicone, Panthenol, Allantoin, Menthol, Bisabolol,
Dipotassium Glycyrrhizate, Carbomer, Phenoxyethanol,
Ethylhexylglycerin, Triethanolamine
Package Label - Principal Display Panel
Undefined (Label)
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