Label: COLD AND HOT CVS- menthol 7.6% mehyl salicylate 29.0% 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 May 10, 2018

If you are a consumer or patient please visit this version.

  • Active ingredients

    Menthol 7.60%
    Methyl Salicylate 29.00%


  • Purpose

    Topical analgesic

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains of muscles and
    joints associated with: • arthritis • simple backache • muscle strains
    • bruises • sprains

  • Warnings

    For external use only.

    Flammable • keep away from fire or flame • do not use while smoking or
    near heat or flame • avoid long term storage above 104˚F. • do not puncture
    or incinerate. Contents under pressure. • do not store at temperatures
    above 120˚F.
    When using this product • avoid contact with eyes and mucous
    membranes • do not apply to wounds or damaged skin • do not bandage
    tightly • use only as directed
    Stop use and ask doctor if • condition worsens • symptoms persist for
    more than 7 days or clear up and occur again within a few days • needed for
    longer than 1 week
    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children.

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

  • Directions

     • shake well • adults and children 2 years of age and older:
    spray product on affected area, not more than 3 to 4 times
    daily. • children under 2 years of age: consult a doctor

  • Inactive ingredients

    Alcohol Denat.
    Arnica Montana Flower Extract
    Boswellia Serrata Gum Extract
    Dimethyl Sulfone
    Eucalyptus Globulus Leaf Oil
    Ilex Paraguariensis Leaf Extract
    Mentha Piperita (Peppermint) Oil
    Olea Europaea (Olive) Fruit Oil
    Propylene Glycol
    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    COLD AND HOT  CVS
    menthol 7.6% mehyl salicylate 29.0% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-269
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE29.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-269-04113 g in 1 CAN; Type 0: Not a Combination Product11/13/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/13/2014
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(59779-269)