Label: CVS COLD AND HOT PAIN RELIEVING STICK- methyl salicylate and menthol stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 30, 2009

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  • Active Ingredients

    Methyl Salicylate 30%

    Menthol 10%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor aches and pains associated with:

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

    For external use only.

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

    Allergy Alert:

    Do not use if allergic to salicylates (including aspirin) without consulting a physician.

  • 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 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
    • irritation develops
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and Children 10 Years of Age or Older

    • Apply generously to affected area
    • Massage area until thoroughly absorbed into skin
    • Repeat as necessary, but no more than 4 times daily
    Children Under 10 Years of Age Consult a doctor
  • INACTIVE INGREDIENT

    Propylene Glycol, Sodium Stearate, Water, Stearic Acid, Cyclopentasiloxane, Hydrogenated Castor Oil, PEG-150 Distearate, Stearyl Alcohol.

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Chattem, Inc.Chattanooga, TN 37409.

    Made in USA

    Distributed by: CVS Pharmacy, Inc.

    Once CVS Drive

    Woonsocket, RI 02895

    (C) 2009 CVS/pharmacy

    www.cvs.com

    1-800-shop-CVS

  • PRINCIPAL DISPLAY PANEL


    .25 OZ MORE

    CVS (R) pharmacy

    NEW! Compare to Icy Hot (R) Chill Stick active ingredients*

    Extra Strength

    COLD and HOT

    Pain Relief

    MENTHOL 10%, METHYL SALICYLATE 30%

    Pain relieving stick

    NET WT 2 OZ (56.7G)

    NDC 10889-202-11 (2 OZ)

    CVS Cold and Hot Label



  • INGREDIENTS AND APPEARANCE
    CVS COLD AND HOT  PAIN RELIEVING STICK
    methyl salicylate and menthol stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10889-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    methyl salicylate (UNII: LAV5U5022Y) (methyl salicylate - UNII:LAV5U5022Y) methyl salicylate30.0 
    menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol10.0 
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10889-202-111 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34803/27/2009
    Labeler - VVF Kansas Services LLC (791425452)
    Establishment
    NameAddressID/FEIBusiness Operations
    VVF Kansas Services LLC791425452manufacture
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