Label: CVS THERAPEUTIC MENTHOL PAIN RELIEVER- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 10, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Menthol 2%...................................................Topical Analgesic
  • PURPOSE



    Uses     for the temporary relief of minor aches and pains of muscles and joints
    associated with - simple backache - bruises  - sprains  - arthritis  - strains
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help or contact a
    Poison Control Center right away.

  • INDICATIONS & USAGE



    Uses for the temporary relief of minor aches and pains of muscles and joints
    associated with - simple backache - bruises  - sprains  - arthritis  - strains
  • WARNINGS

    Warnings

    For external use only

    When using this product
    - do not bandage tightly - avoid contact with the eyes
    - do not apply to wounds or damaged skin
    - do not use with heating pads or other heating devices

    Stop use and ask a doctor if - condition worsens or 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


    Directions
    - adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily

    - children under 12 years of age: do not use, consult a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients


    carbomer 934, FDandC blue no. 1, isopropyl alcohol, menthol, sodium hydroxide, thymol, water
  • PRINCIPAL DISPLAY PANEL


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  • INGREDIENTS AND APPEARANCE
    CVS THERAPEUTIC MENTHOL PAIN RELIEVER 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    THYMOL (UNII: 3J50XA376E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-056-361 in 1 CARTON
    1227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34807/10/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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