Soothanol X2 by NewMarket Health Products LLC Soothanol X2

Soothanol X2 by

Drug Labeling and Warnings

Soothanol X2 by is a Otc medication manufactured, distributed, or labeled by NewMarket Health Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOOTHANOL X2- menthol, unspecified form,capsaicin liquid 
NewMarket Health Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Soothanol X2

Active Ingredient section

 Menthol, Unspecified Form   12%

Capsaicin 0.20%

Purpose

Topical Analgesic

Uses

for temporary relief of minor aches and pains of muscles and joints associated with:
Simple backache
Arthritis
Strains
Bruises
Sprains

Warnings

For external use only.

When using this product
Avoid contact with eyes or mucus membranes.
Do not bandage tightly.
Do not apply to wounds or damaged skin.

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 of skin develops.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

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

Directions

Adults and children 12 years of age and older: wash hands and affected area with lukewarm water and apply 2 – 3 drops with fingertips not   more than 3 to 4 times daily.
Children under 12 years of age: consult a physician.
Do not use otherwise than as directed.

Other Information.

Store in a cool, dry place.

• Questions or comments? Call (800) 895-2108, Monday through Friday, 8am-8pm EST
• www.NorthStarNutritionals.com

Inactive Ingredients

Arnica Flower, Calendula Flower, Dimethyl Sulfoxide (DMSO), d-Limonene Oil, Emu Oil (non-vegetarian), Extra Virgin Olive Oil, Ginger Root,

Methylsulfonylmethane (MSM), St. John’s Wort, Wintergreen Oil

Product Image

SOOTHANOL X2 
menthol, unspecified form,capsaicin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50972-767
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	120 mg  in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
EMU OIL (UNII: 344821WD61)
OLIVE OIL (UNII: 6UYK2W1W1E)
GINGER (UNII: C5529G5JPQ)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ST. JOHN'S WORT (UNII: UFH8805FKA)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50972-767-01	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/11/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/11/2014	09/30/2021

Labeler - NewMarket Health Products LLC (055293706)

Revised: 9/2021

Document Id: cc83a07a-8d34-9fba-e053-2a95a90a0dae

34390-5

Set id: 74bbc671-2b5c-400b-8c91-f47933e0b679

Version: 2

Effective Time: 20210921