Label: SOOTHANOL X2- capsaicin and menthol solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 31, 2017

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  • 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

    SoothanolX2

  • INGREDIENTS AND APPEARANCE
    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)
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