Label: MENTHOL AND METHYL SALICYLATE stick

  • 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 March 1, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    PAIN RELIEVING STICK
    Drug Facts

  • Active ingredient

    Menthol 10%

    Methyl salicylate 30%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain associated with:

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

    For external use only

    SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

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

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin

    Stop use and ask a doctor 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 care professional before use.

    Keep out of reach of children.

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

  • Directions

    adults and children over 12 years:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but not more than 4 times daily

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)

    Repacked by:
    H.J. Harkins Company, Inc.
    513 Sandydale
    Nipomo, CA 93444

  • PRINCIPAL DISPLAY PANEL

    MM1

  • INGREDIENTS AND APPEARANCE
    MENTHOL AND METHYL SALICYLATE  
    menthol and methyl salicylate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-028(NDC:41167-0089)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-028-0349 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34806/01/1991
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chattem Plant 1003336013MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Chattem Plant 2830410721MANUFACTURE
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!