Label: SPORT IQ PAIN RELIEF- menthol cream

  • NDC Code(s): 72667-064-01, 72667-064-02
  • Packager: Inspec Solutions LLC.
  • 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 January 3, 2023

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  • Active Ingredient

    Menthol 8%

  • PURPOSE

    Uses Temporary relief from minor aches and pains of muscles and joints associated with, arthritis, simple backache, strains, bruises, sprains.

  • Warning

    For external use only

  • WHEN USING

    When using this product, avoid contact with eyes and mucous membranes., do not apply to wound or damage skin, do not bandage, do not use with heating pad or device.

  • STOP USE

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Abies Sibirica (Fir) Needle Oil

    Aloe barbadensis (Aloe Vera) Leaf Juice

    Beeswax

    Caprylyl Glycol

    Carthamus tinctorius (Safflower) seed oil

    Cetyl PEG/PPG-10/1 Dimethicone

    Chlorphenesin

    Cinnamomum camphora bark oil

    Eucalyptus globulus Leaf Oil

    Helianthus annuus (sunflower) seed oil

    Methyl salicylate

    PEG-40 Hydrogenated Castor Oil

    Phenoxyethanol

    Sodium Chloride

    Water

  • INDICATIONS & USAGE

    Uses Temporary relief from minor aches and pains of muscles and joints associated with, arthritis, simple backache, strains, bruises, sprains

  • PRINCIPAL DISPLAY PANEL

    Sport IQ Pain Relief Cream 3.4 ozSportIQ Pain Relief 8OZ

  • INGREDIENTS AND APPEARANCE
    SPORT IQ PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-064-01226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    2NDC:72667-064-02100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/03/2023
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-064)
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