Directions For Use
Adults and children 2 years of age and older: apply to affected area
Owell Naturals Maximum Strength Leg Pain Relief Cream
FDA Label NDC 83570-008
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 Maximum Strength Leg Pain Relief (NDC 83570-008). 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 directions for use, uses/claims, active ingredients, general safety warnings, contraindications, ask doctor section, precautions, 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
Uses/Claims
For the temporary relief of minor aches and pains.
Active Ingredients
Menthol 8%
General Safety Warnings
For external use only. Do not use in eyes
Contraindications
Do not use on damaged or broken skin
Ask Doctor Section
Pre-existing conditions requiring medical consultation.
Precautions
Avoid contact with eyes", "Do not bandage tightly
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.
Purpose
Topical Analgesic
Inactive Ingredients
Water, Carthamus Tinctorius (Hybrid Safflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe Barbadensis Leaf Juice, Beeswax, Hydrogenated Castor Oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus Globulus Leaf Oil, Helianthus Annuus (Sunflower) Seed Oil, Cinnamomum Camphora Bark Oil, Abies Sibirica Needle Oil, Methyl Salicylate, Sodium Chloride, Dimethyl Sulfone (MSM), Arnica Montana, Pyridoxine Hydrochloride (Vitamin B6), and Tocopherol (Vitamin E).
Principal Display Panel - Leg Pain Relief Cream
1
Leg Cream2oz (Legpaincream 2oz)
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