Owell Naturals Deep Penetrating Pain Relief Ointment
FDA Label NDC 83570-443

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 Owell Naturals Deep Penetrating Pain Relief (NDC 83570-443). 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 ingredients, purpose, uses:, warnings, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredients

Menthol 7.66%

Purpose

Topical Analgesic

Uses:

  • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. 
  • Provides cooling pain relief.

Warnings

For External Use Only.

Do Not Use

  • on damaged or broken skin.

When Using This Product

  • keep out of eyes. Rinse with water to remove
  • Do not bandage tightly.

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts.
  • 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.

If swallowed, get medical help, or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

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.

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Camphor, Eucalyptus Globulus Oil, Methyl Salicylate, Petrolatum, Pinus Palustris Pine) Oil

Questions?

Customer Care: 1.800.203.9451

Package Labeling: 60Ml

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Package Labeling: 103.5Ml

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