SOOTHANOL X2- capsaicin and menthol solution/ drops

Soothanol X2 by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Capsaicin 0.20%

Menthol 12%

PURPOSE

Purpose

Topical Analgesic

Topical Analgesic

INDICATIONS & USAGE

Uses for temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

Warnings

For external use only.

When using this product

• avoid contact with eyes or mucus membranes
• do not bandage tighly
• do not apply to wounds or damaged skin

Stop use and ask 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 breast feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

Store in a cool, dry place.

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments?

Call (800) 895-2108, Monday through Friday, 8am-8pm EST

www.NorthStarNutritionals.com

PRINCIPAL DISPLAY PANEL

North Star 

Nutritionals 

SOOTHANOL X2 

Pain Relieving Drops 

Net: 1 Fluid OZ/ 30 ML

INGREDIENTS AND APPEARANCE

SOOTHANOL X2 
capsaicin and menthol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50972-766
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ARNICA ANGUSTIFOLIA FLOWER (UNII: NG0U89QRD8)
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: 50972-766-01	1 in 1 BOX	06/11/2014
1		28.3 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

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

Labeler - NewMarket Health Products LLC (055293706)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works, Inc.		137752817	manufacture(50972-766)