Active Ingredient(S)
Arnica montana HPUS 7%
Pioelly Arnica Bruise Cream
FDA Label NDC 84558-029
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 Pioelly Arnica Bruise Cream (NDC 84558-029). 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
Temporarily relieves muscle pain and stiffness; reduces symptoms of bruising such as
pain, swelling and discoloration.
Use
Temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and
falls. Helps reduce symptoms of bruising such as pain, swelling and discoloration.
Warnings
For external use only.
Do Not Use
Do not use if you are allergic to amica or to any inactive ingredient.
Otc - When Using
When using this product, avoid contact with eyes, mucous membranes, wounds,
damaged skin or irritated skin. Use only as directed. Do not tightly
wrap or bandage the treated area. Do not apply heat or ice to the treated area
immediately before or after use.
Otc - Stop Use
Excessive skin irritation occurs; symptoms worsen; symptoms persist for
more than 7 days; or symptoms clear up and occur again 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
Apply a thin layer to the affected area as soon as possible after a minor injury.Repeat 3
times daily or as needed. If heat or ice has been applied, wait at least 5 minutes before
applying. Wash hands after use.
Other Information
Store at room temperature. Avoid excessive heat and direct sunlight. Do not use if safety
seal is broken or missing.
Inactive Ingredients
Aqua, Magnesium Chloride, Methylsulfonylmethane, Butyrospermum Parkii Butter,
Simmondsia Chinensis Seed Oil, Glycerin, Propylene Glycol, Cetearyl Alcohol, Glyceryl
Stearate,Aloe Barbadensis Leaf Extract, Phenoxyethanol, Lavandula Angustifolia Oil,
Ethylhexylglycerin, Tocopheryl Acetate,Carbomer, Triethanolamine, Pyridoxine,
Menthol, Sodium Hyaluronate,Ascorbic Acid, Vanillyl Butyl Ether, Phytonadione
Package Label - Principal Display Panel
Undefined (Label)
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