Otc - Active Ingredient
Arnica Montana 1x HPUS
Dr. Luke Arnica Bruise Cream
FDA Label NDC 87147-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Danous Land Floow Llc for the product Dr. Luke Arnica Bruise Cream (NDC 87147-004). 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, otc - when using, otc - do not use, otc - keep out of reach of children, warnings, inactive ingredient, instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Reduces pain, swelling, and discoloration from bruises
Otc - When Using
Avoid contact with eyes, mucous membranes. If contact occurs, rinse with water.
Use only as directed
Do not tightly wrap or bandage the treated area.
Do not apply heat or ice to the treated area immediately.
Otc - Do Not Use
Do not apply to open wounds or broken skin.
You are allergic to arnica montana, or other inactive ingredients in this product
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
For external use only.
Inactive Ingredient
Water, Glycerin, Cocos Nucifera (Coconut) Oil, Grape Seed Oil,Dimethicone, Beeswax, Acrylates Crosspolymer-6, Niacinamide, Hippophae
Rhamnoides Fruit Oil, Trehalose, Propylene Glycol, Phytonadione (Vitamin
K1), Hydroxyethylcellulose, Polyacrylamide, Vitamin E, Vitamin C, Lavender
Oil, Rosemary Leaf Oil, Boswellia Carterii (Frankincense) Oil, Panax
Notoginseng Root Extract, Liposomal Curcumin, Laureth-7, 1,2-Hexanediol,
pH Adjusters, Ethylhexylglycerin, Polysorbate 60.
Instructions For Use
Apply a thin layer of bruise cream to affected areas 3 times daily.
Massage gently until fully absorbed.
For best results, use consistently until appearance improves.
Indications & Usage
Reduces symptoms of bruising such as: Pain, Swelling, Discoloration
Dosage & Administration
Apply to affected area not more than 3–4 times daily.
Other Safety Information
Do not use if glued carton end flaps are open or if the tube seal is broken.
Store at 68°-77°F (20°-25C).
Keep container tightly closed
Package Label.Principal Display Panel
Label (20251110 085336)
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