Label: MENTHOL- therapain plus spray spray

  • Category: HUMAN OTC DRUG LABEL

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 13, 2022

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  • Warnings

    For external use only. If accidentally ingested contact poison control immediately.

  • Active Ingredients

    Natural L-Menthol 2%

  • Purpose

    Topical Analgesic

  • KEEP OUT OF REACH OF CHILDREN

  • Inactive Ingedients

    Deionized Water, Isopropyl Alcohol, Oil of Peppermint, Oil of Eucalyptus, Proprietary Skin Conditioner.

  • Directions

    Directions

  • Stop use section

    Stop use and ask a doctor if

    • Excessive skin irritation develops
    • Conditions worsens
    • Symptoms persist more than 7 days, discontinue use of this product and consult a doctor
  • Uses

    Relieves temporary pain due to

    arthiritus

    neck and back pains

    stiffness

    msucle soreness

    cramps

    sprains and strains

    tendonitis

  • PDP

    Label Proof

  • INGREDIENTS AND APPEARANCE
    MENTHOL 
    therapain plus spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67285-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 34.17 g  in 100 mL
    EUCALYPTUS OIL (UNII: 2R04ONI662) 0.083 g  in 100 mL
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) 1.67 g  in 100 mL
    PEPPERMINT OIL (UNII: AV092KU4JH) 0.208 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 51.829 g  in 100 mL
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) 8.33 g  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.67 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67285-102-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/18/2020
    Labeler - Relief-Mart, Inc (124312344)
    Registrant - Relief-Mart, Inc (124312344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Generitech Corporation138352435manufacture(67285-102)
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