Label: DCH COOLING PAIN RELIEF- menthol 10.5% spray

  • NDC Code(s): 72839-639-03
  • Packager: Derma Care Research Labs, LLC
  • 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 July 19, 2023

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  • ACTIVE INGREDIENT

    Menthol 10.5%

  • PURPOSE


    Topical Analgesic

  • INDICATIONS & USAGE

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

  • 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

    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
    DCH COOLING PAIN RELIEF 
    menthol 10.5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-639
    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
    ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    WATER (UNII: 059QF0KO0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-639-0385 g in 1 CAN; Type 0: Not a Combination Product05/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/24/2021
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-639)
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