CVS MEDICATED PAIN RELIEVING (CAMPHOR, MENTHOL, MENTHYL SALICYLATE) PATCH [CVS PHARMACY, INC.]

CVS MEDICATED PAIN RELIEVING (CAMPHOR, MENTHOL, MENTHYL SALICYLATE) PATCH [CVS PHARMACY, INC.]
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NDC 59779-551-40
Set ID 84ce8bbd-51b7-4915-8e70-1d22999e34dc
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients                                                                Purpose

    Camphor 1.2%.......................................................Topical Analgesic

    Menthol 5.7%.........................................................Topical Analgesic

    Menthyl Salicylate 6.3%..........................................Topical Analgesic

  • PURPOSE

    Uses For temporary relief of minor aches and pains of muscles and joints associated with:

    • arthritis
    • simple backache
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings For external use only
    Allergy alert: if prone to allergic reation from aspirin or salicylates, consult a doctor before use.

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product
    • on a child under 12 years of age with arthritis-like conditions
  • ASK DOCTOR

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

  • WHEN USING

    When using this product

    • do not use otherwise than directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a bath or shower
  • STOP USE

    Stop use and ask a doctor if

    • redness is present or irritation or rash develops
    • conditions worsen or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
  • 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 (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    Adults and children 12 years of age and over:

    • Clean and dry affected area
    • Remove patch from film
    • Apply to affected area not more than 3 to 4 times daily
    • do not wear patch for more than 8 hours

    Children under 12 years of age: consult a doctor

  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
    • avoid storing product in direct sunlight
    • protect product from excessive moisture
  • INACTIVE INGREDIENT

    Inactive ingredients

    butylated hydroxytoluene, glyceryl rosinate, nautral rubber, polybutene, polysobutylene, precipitated calcium carbonate, quinton, sorbitan stearate, tocopherol acetate, YS resin, zinc oxide

  • DOSAGE & ADMINISTRATION

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    51783.1

  • INGREDIENTS AND APPEARANCE
    CVS MEDICATED PAIN RELIEVING 
    camphor, menthol, menthyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-551
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)28.4 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL131 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE144 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-551-402 in 1 BOX06/30/2013
    120 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2013
    Labeler - CVS Pharmacy, Inc. (062312574)

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