Purpose
Topical Analgesic
Pain Relief Spray
FDA Label NDC 83570-003
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 Brand, Llc for the product Pain Relief (NDC 83570-003). 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 purpose, active ingredient, inactive ingredients, uses, warnings, keep out of reach of children, directions, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 7.6%
Inactive Ingredients
Camphor Oil (White), Eucalyptus Oil, Methyl Salicylate, Mineral Oil, Pine Needle Oil.
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.
Flammable: Keep away from fire or flame.
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, 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 2 years of age and older: Spray on affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.
Principal Display Panel
Product Label (On10528 Painreliefspray Page 0001)
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