Label: PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON- menthol gel

  • 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 February 3, 2022

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  • Drug Facts

  • Active Ingredients

    Menthol 3.5%

    Purpose

    Pain Relieving Gel

  • Uses:

    Temporarily relieves minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    ​For external use only.

    Flammable:

    Keep away from excessive heat and open flame.

    When Using This Product:

    • use only as directed
    • Avoid contact with the eyes or mucous membranes
    • do not apply to wounds or damaged skin
    • do not apply to irritated skin or if excessive irritation develops
    • do not bandage tightly or use with heating pad or device

    Stop Use and Ask Doctor If:

    • you experience pain, swelling or blistering of the skin
    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

    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:

    • adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a physician
    • wash hands after use with cool water
  • Other Information:

    • store at 20-25C (68-77F)
    • store in a cool dry place away from direct sunlight
  • Inactive Ingredients:

    Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Blue 1, Camelia Sinensis Leaf Extract, Carbomer, Citrus Aurantifolia (lime) Oil, Citrus Auratium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Glycerin, Hypericum Perforatum Oil, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Lavandula Hybrida Oil, Mentha Piperita (Peppermint) Oil, Myristica Fragrans (Nutmeg) Kerneol Oil, Pinus Sylvestris Leaf Oil, Polysorbate 20, Silica, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Triethanolamine, Water.

  • Questions or Comments?

    1-800-246-3733

  • PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label

    NDC 59316-112-10

    PERFORM®

    MENTHOL-PAIN
    RELIEVING
    GEL
    COOL + SOOTHING
    FOR SORE MUSCLES
    AND JOINTS

    FAST-ACTING

    ROLL-ON

    3 FL OZ (89 mL)

    PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPERICUM OIL (UNII: OZU2FC70HY)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    THYME OIL (UNII: 2UK410MY6B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-112-101 in 1 CARTON05/18/2015
    189 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/18/2015
    Labeler - RB Health (US) LLC (081049410)
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