Label: CVS EXTRA STRENGTH PAIN RELIEF- menthol, methyl salicylate gel

  • 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 10, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Menthol 7.6%...................................................Topical Analgesic
    Methyl Salicylate 29%.......................................Topical Analgesic
  • PURPOSE



    Uses     temporary relieves minor pain associated with:

    - arthritis - simple backache - muscle strains
    - muscle sprains - bruises - cramps

  • 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 temporary relieves minor pain associated with:

    - arthritis - simple backache - muscle strains
    - muscle sprains - bruises - cramps

  • WARNINGS

    Warnings

    For external use only


    Allergy alert:      if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    When using this product     - use only as directed - avoid contact with the eyes or mucous membranes
    - do not bandage tightly or use with a heating pad - do not apply to wounds or damaged skin

    Ask a doctor before use if - condition worsens - redness is present - irritation develops - symptoms persist
    for more than 7 days or clear up and occur again within a few days.

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

    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 generously to affected area
    - massage into painful area until thoroughly absorbed into skin
    - repeat as necessary, but no more than 4 times dily

    children under 12 years of age: consult a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients parrafin, petrolatum
  • PRINCIPAL DISPLAY PANEL


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  • INGREDIENTS AND APPEARANCE
    CVS EXTRA STRENGTH PAIN RELIEF 
    menthol, methyl salicylate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-620
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL76 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE290 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-620-3599.2 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/10/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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