Active Ingredient
Menthol 8%
Maximum Strength Pain Relief Cream
FDA Label NDC 83570-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Owell Naturals Llc for the product Maximum Strength Pain Relief (NDC 83570-004). 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 active ingredient, purpose, uses, warnings, directions, inactive ingredients, keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
Temporarily relieves 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. Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.
Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.
Inactive Ingredients
Water, Safflower Seed Oil, Sunflower Seed Oil Glycereth-8 Esters, Cetyl PEG/PPG-10/1 Dimethicone, Aloe Vera Leaf Juice, Beeswax, Hydrogenated Castor Oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus Leaf Oil, Camphor Bark Oil, Siberian Pine Needle Oil, Methyl Salicylate, Sodium Chloride, Chlorphenesin.
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.
Package Label.Principal Display Panel
Product Label 4oz (On10510 On Npainreliefcream 6.25x1.75 4oz)
Product Label 8oz (On10509 On Npainreliefcream 8x2 8oz)
Product Label 15oz (On10512 On Npainreliefcream 10x25 15oz)
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