Active Ingredient(S)
Arnica Montana Flower
Extract 1X HPUS 9%
Putrizen Arnica Bruise Relief Cream
FDA Label NDC 84558-030
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 84558-030). 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 Minor Bruises, Muscle Soreness & Swelling
from injuries, discoloration associated with bruising.
Use
For the temporary relief of pain, swelling, and discoloration due to
▪ minor bruising ▪ muscle overexertion ▪ or skin discomfort.
Warnings
For external use only.
Do Not Use
▪ Do not use if you are allergic to Arnica Montana or any of the ingredients.
▪ Avoid contact with eyes, mucous membranes, or broken skin.
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
▪ Stop use and ask a doctor if condition worsens or symptoms persist for
more than 3 days.
Otc - Keep Out Of Reach Of Children
▪ Keep out of reach of children. ln case of ingestion, seek medical help or
contact a Poison Control Center immediately.
Directions
Apply a thin layer to the affected area 2-3 times daily. Gently massage
into fragile or delicate skin areas. If heat or ice is applied, wait 5 minutes
before applying Arnica Bruise 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,
Phylloquinone, Ascorbic Acid, Tocopherol, Allantoin, Triethanolamine,
Menthol, Bisabolol, Dipotassium Glycyrrhizate
Package Label - Principal Display Panel
label
Undefined (Label)
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