Label: ZURFLEX- pain relief spray spray

  • 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 November 12, 2020

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  • Active Ingredient

    Menthol 9%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor pain associated with

    • simple backache
    • arthritis
    • tendonitis
    • strains
    • sprains
    • pulled ligaments
    • sore/stiff muscles
    • sports injuries
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • avoid contact with eyes
    • do not apply to open wounds or damaged skin
    • do not bandage tightly or use a heat pad

    Stop use and ask a doctor if

    • condition worsens or if symptoms persist for more than 7 days
    • irritation develops
    • redness is present

    If pregnant or breast-feeding

    ask a health professional; before use

    Keep out of the reach of children

    If accidentally ingested, seek medical help or contact a Poison Control Center immediately, Replace cap firmly.

  • Directions

    • repeat as necessary but no more than 4 times daily

    Children 2 years or younger ask a doctor

  • Flammable

    Do not use near flame or heated surface. Store at room temperature.

  • Inactive Ingredients

    Eucalyptus Oil, isopropyl alcohol, Spearmint Oil, Water

  • Bottle Label

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    ZURFLEX 
    pain relief spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72668-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL90 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72668-001-01237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2020
    Labeler - Basler Health Care Group (794923128)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAKA USA Inc. dba Cosmetic Inoovations802860515manufacture(72668-001)
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