NORTH STAR NUTRITIONALS SOOTHANOL X3 PAIN RELIEVING DROPS- menthol liquid

Drug Labeling and Warnings

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

NORTH STAR NUTRITIONALS SOOTHANOL X3 PAIN RELIEVING DROPS 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50972-950
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	130 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAPSAICIN (UNII: S07O44R1ZM)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
EMU OIL (UNII: 344821WD61)
METHYL SALICYLATE (UNII: LAV5U5022Y)
GLYCERIN (UNII: PDC6A3C0OX)
HYPERICUM PERFORATUM LEAF (UNII: DOC7OB843Y)
OLIVE OIL (UNII: 6UYK2W1W1E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50972-950-00	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/08/2026

Labeler - NEWMARKET HEALTH PRODUCTS, LLC (828825989)

Registrant - Pure Source, LLC (080354456)