Active Ingredient(S)
Arnica Montana Flower
Extract 1X HPUS 15%
Putrizen Arnica Bruise Relief Cream
FDA Label NDC 84558-028
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 Putrizen Arnica Bruise Relief Cream (NDC 84558-028). 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 soreness, swelling
and discoloration associated
with minor bruising.
Use
Temporarily relieves symptoms associated with minor bruising, including:
· minor pain
· swelling
· discoloration
Warnings
For external use only.
Do Not Use
Do not use if you are sensitive to Arica Montana Flower.
Otc - When Using
. avoid contact with eyes and mucous membranes
. use only as directed
. do not tightly wrap or bandage the treated area
· do not use with a heating pad
Otc - Stop Use
the condition worsens
symptoms persist for more than 3 days
excessive irritation, redness, or rash occurs
symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact
Poison Control right away.
Directions
Apply a thin layer to the affected area 2-3 times daily.Gently
massage until absorbed, using light pressure on mature or delicate
skin. If using heat or ice, remove it and wait at least 5 minutes before
applying the cream.
Other Information
Store at 68°-77°F(20°-25°C). Protect from heat and direct sunlight.
Inactive Ingredients
Water, Glycerin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Propylene
Glycol, Glyceryl Stearate,PEG-100 Stearate,Dimethicone, Phenoxyethanol,
Carbomer,Panthenol, Ethylhexylglycerin, Phytonadione, Ascorbic Acid,
Tocopherol, Allantoin, Triethanolamine, Menthol, Bisabolol,
Dipotassium Glycyrrhizate, Ceramide NP, Squalane.
Package Label - Principal Display Panel
Undefined (Label)
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