Label: CVS COLD HOT MEDICATED- 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 October 14, 2013

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
    • Bruises
    • Cramps
  • 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 Poision Control Center right away.

  • INDICATIONS & USAGE

    Directions: adults and children 12 years of age and older

    • Peel off protective backing and apply sticky side to affected area
    • Carefully remove backing from patch
    • Should be used up to 8 hours
    • Should be used no more than 3 times a day
    • Children under 12 years of age consult a doctor
  • STORAGE AND HANDLING

    Other Information

    • Store at room temperature, not to exceed 86° (30°C)
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    1,3 butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disodium edetate, d-sorbital solution, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium methaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    CVS PHARMACY, INC.

    ONE CVS DRIVE

    WOONSOCKET, RI 02895 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CVS COLD HOT MEDICATED 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-821
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-821-055 in 1 BOX
    1.05 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/14/2013
    Labeler - CVS Pharmacy Inc. (062312574)