Label: CVS MEDICATED PAIN RELIEVING- camphor, menthol, menthyl salicylate 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 July 3, 2019

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  • 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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