Active Ingredient
Menthol 8.0%
Owell Naturals Arthritis Maximum Strength Cream
FDA Label NDC 83570-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Owell Natural 8 Llc for the product Owell Naturals Arthritis Maximum Strength (NDC 83570-007). 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, uses, warnings, keep out of reach of children., directions, inactive ingredients, purpose, principal display panel - 2 fl oz bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings
For external use only.
Do not use on wounds or damaged skin.
When using this product avoid contact with eyes or mucous membranes; do not bandage tightly.
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Keep Out Of Reach Of Children.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 12 years of age: Consult a doctor.
Inactive Ingredients
Aloe Vera Leaf, Arnica Montana, Beeswax, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Eucalyptus Oil, Hydrogenated Castor Oil, Phenoxyethanol, Pyridoxine Hydrochloride, Safflower Oil, Sodium Chloride, Sunflower Oil, Vitamin E Polyethylene Glycol Succinate, Camphor Bark Oil, Dimethyl Sulfone.
Purpose
Topical Analgesic
Principal Display Panel - 2 Fl Oz Bottle Label
PRINCIPAL DISPLAY PANEL - 2 FL OZ Bottle Label
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