SOOTHANOL X2- capsaicin and menthol solution/ drops 
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 Ingredients

Capsaicin 0.20%

Menthol 12%

Purpose

Topical Analgesic

Topical Analgesic

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

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.

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

Directions

Other information

Store in a cool, dry place.

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 or comments?

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

www.NorthStarNutritionals.com

North Star 

Nutritionals 

SOOTHANOL X2 

Pain Relieving Drops 

Net: 1 Fluid OZ/ 30 ML

SoothanolX2

SOOTHANOL X2 
capsaicin and menthol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50972-766
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN2 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL120 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50972-766-011 in 1 BOX06/11/2014
128.3 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/11/2014
Labeler - NewMarket Health Products LLC (055293706)
Establishment
NameAddressID/FEIBusiness Operations
Vitality Works, Inc.137752817manufacture(50972-766)

Revised: 8/2017
Document Id: cc878010-66e4-4cd0-8282-33ef5142ff10
Set id: 29ea4b34-dff7-40de-82b4-9b2dd1eb32ca
Version: 2
Effective Time: 20170831
 
NewMarket Health Products LLC