Label: RELIEVEIT FOOTSPRAY TOPICAL ANALGESIC- menthol 8% liquid

  • 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 March 13, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 8.0%

  • Purpose

    External analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles, joints and feet.

  • Warnings

    for external use only

    When using this product: use only as directed• avoid contact with eyes or mucous membrane• do not apply to open wounds, damaged or very sensitive skin • Do not use if you are allergic to any of this product's Active or Inactive ingredients

    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

    • Spray balls of feet. arches, heels, toes and legs on bare skin before starting your day or activity:

    6 - 8 sprays each foot· Apply generously when wearing stockings; 8+ sprays each foot

    • Let dry completely • Apply again as needed for extended relief

    Children under 2: consult a doctor before use

  • Inactive ingredients

    Arnica Montona, Cyclomethicone, Ethyl Alcohol. Ethoxydiglycol. Eucalyptus Oil. Horpogophytum. lsopropyl Palmitate, Lemon Oil, Lemongrass Oil, Pinus Resin, Propylene Glycol, Peppermint Oil, Teo Tree Oil, Wintergreen Oil

  • SPL UNCLASSIFIED SECTION

    Manufactured for: SprainGo, LLC

    3802 Spectrum Blvd, Suite 112E

    Tampa, FL 33612

    Made in the USA

  • Other Information

    • Do not use if the package seal is broken• Store at 68-77°F (20 -25°)

    • Keep this package. It contains important information on directions for use

  • PRINCIPAL DISPLAY PANEL

    refilllabel

  • INGREDIENTS AND APPEARANCE
    RELIEVEIT FOOTSPRAY  TOPICAL ANALGESIC
    menthol 8% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-956
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.2 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    BIS-ETHOXYDIGLYCOL CYCLOHEXANE 1,4-DICARBOXYLATE (UNII: R6MU0U9L45)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LEMON OIL (UNII: I9GRO824LL)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    1-(3-AMINO-4-HYDROXYPHENYL)-2-((2-(4-METHOXYPHENYL)-1-METHYLETHYL)AMINO)ETHANOL (UNII: GJY78AX70Q)  
    PINUS RESINOSA WHOLE (UNII: AS8B4M6X9N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PROPYLENE GLYCOL 1-ALLYL ETHER (UNII: QRB8092KPK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-956-0130 mL in 1 CARTON; Type 0: Not a Combination Product03/13/2020
    2NDC:58133-956-0230 mL in 1 CARTON; Type 0: Not a Combination Product03/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/13/2020
    Labeler - Cosmetic Specialty labs, Inc. (032973000)
    Registrant - Cosmetic Specialty labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty labs, Inc.032973000manufacture(58133-956)
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