CVS VANISHING SCENT MUSCLE RUB (MENTHOL) GEL [CVS PHARMACY]

CVS VANISHING SCENT MUSCLE RUB (MENTHOL) GEL [CVS PHARMACY]
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NDC 59779-054-04
Set ID 24bfcd71-9d9c-4f56-9543-6fbcc15058d7
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Menthol 2.5%.................................................Topical Analgesic
  • PURPOSE



    Uses
    temporarily relieves the minor aches and pains of muscles and joints associated with
    - simple backache - atrhritis - strains - bruises - sprains

  • 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 temporarily relieves the minor aches and pains of muscles and joints associated with
    - simple backache - atrhritis - strains - bruises - sprains

  • WARNINGS

    Warnings

    For external use only


    Do not use

    - on wounds or damaged skin
    - with a heating pad
    - on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have redness over the affected area.

    When using this product
    - avoid contact with the eyes or mucous membranes
    - do not bandage tightly

    Stop use and ask a doctor if
    - condition worsens or symptoms persist for more than 7 days
    - symptoms clear up and occur again within a few days
    - excessive skin irritation occurs.

    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 the affected area not more than 3 to 4
    times daily.

    Children under 12 years of age - consult a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients


    camphor, carbomer, diazolidinyl urea, isopropyl alcohol, nonoxynol-9, potassium hydroxide, purified water
  • PRINCIPAL DISPLAY PANEL


    c

  • INGREDIENTS AND APPEARANCE
    CVS VANISHING SCENT MUSCLE RUB 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL27.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-054-041 in 1 CARTON
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/14/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture

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