Label: CVS ULTRA STRENGTH PAIN RELIEVING- menthol patch

  • 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 December 3, 2015

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

  • Drug Facts

    Active ingredient                                                    Purpose

    Menthol 5%                                                             Topical Analgesic

  • PURPOSE

    Uses Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle strains
    • muscle sprains
    • bruises cramps
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin irritation develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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

    Directions

    • open pouch and remove patch if desired, cut patch to size, peel off protective backing and apply sticky side to affected area
    • 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: consult a doctor
  • STORAGE AND HANDLING

    Other information

    • store between 20° and 25° C (68° and 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients butylated hydroxytoluene, carboxymethylcellulose sodium, caster oil, concentrated glycerin, EDTA-2Na, gelatin, isopropyl myristate, kaolin, magnesium aluminium hydroxide, methylparaben, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

  • DOSAGE & ADMINISTRATION

    Distributed By:

    CVS Pharmacy, Inc.

    One CVS Drive.

    Woonsocket, RI 02895

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CVS ULTRA STRENGTH PAIN RELIEVING 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-476
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-476-041 in 1 CARTON
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/20/2013
    Labeler - CVS Pharmacy, Inc. (062312574)