Label: MEIJER PAIN RELIEF- menthol 10.5% 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 January 4, 2023

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  • ACTIVE INGREDIENT

    Menthol 10.5%

  • PURPOSE


    Topical Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.

  • WARNINGS

    For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

  • INACTIVE INGREDIENT

    Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    MEIJER PAIN RELIEF 
    menthol 10.5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0639
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ALCOHOL (UNII: 3K9958V90M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0639-385 g in 1 CAN; Type 0: Not a Combination Product03/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/31/2021
    Labeler - Meijer (006959555)
    Registrant - Derma Care Research Labs, LLC (116817470)
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