North Star Nutritionals Soothanol X3 Pain Relieving Drops Liquid
FDA Label NDC 50972-950

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Newmarket Health Products, Llc for the product North Star Nutritionals Soothanol X3 Pain Relieving Drops (NDC 50972-950). 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 drug facts, active ingredients, purpose, uses, warnings, keep out of reach of children., stop use and ask a doctor if:, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Menthol 13%

Purpose

Topical Analgesic

Uses

For temporary relief of:

• Muscle aches • Joint pain • Backaches • Arthritis discomfort • Strains and sprains

Warnings

  • For external use only.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to damaged or irritated skin.
  • Do not bandage tightly.

Keep Out Of Reach Of Children.

If swallowed get medical help or contact a Poison Control Center immediately.

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.
  • Excessive irritation occurs

If Pregnant Or Breast Feeding,

ask a health professional before use.

Directions

  • Adults and children 12 years of age and older: Dispense a small amount using the dropper. Apply to affected area. Massage gently until absorbed. Use up to 3–4 times daily or as directed by a healthcare professional.
  • Children under 12 years of age: consult a physician.
  • Do not use otherwise than as directed.

Other Information

 Store at 15–30°C (59–86°F). Keep container tightly closed. Protect from heat and direct sunlight.

Inactive Ingredients

Arnica Montana Extract, Calendula Officinalis Extract, Capsaicin, Dimethyl Sulfone (MSM), Dimethyl Sulfoxide (DMSO), Emu Oil (Dromaius), Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycerin, Hypericum Perforatum (St. John’s Wort) Leaf Extract, Olea Europaea (Olive) Fruit Oil,Propylene Glycol, Water (Aqua).

Questions? Need To Refill?

(800)913-2592 • www.NorthStarNutritionals.com

Package Labeling:

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