CVS THERAPEUTIC MENTHOL PAIN RELIEVER (MENTHOL) GEL [CVS PHARMACY]

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CVS THERAPEUTIC MENTHOL PAIN RELIEVER (MENTHOL) GEL [CVS PHARMACY]
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NDC 59779-056-36
Set ID d60c6b4b-e7f8-4a51-b532-79bc51b38697
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART348
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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


    c

  • 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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