Label: MEIJER COLD AND HOT PAIN RELIEVING- menthol 16% 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 16%

  • PURPOSE


    Topical Analgesic

  • INDICATIONS & USAGE

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

  • 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., Glycerin, Propylene Glycol, Water

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    MEIJER COLD AND HOT PAIN RELIEVING 
    menthol 16% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-5129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-5129-4113 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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