Label: MENTHOL- menthol, unspecified form patch

  • NDC Code(s): 71391-128-01, 71391-128-05
  • Packager: Unexo Life Sciences Private Limited
  • 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 November 9, 2022

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 7.5%

  • PURPOSE

    Topical analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints due to:

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

    For external use only

    Ask a doctor before use if you have

    • Sensitive skin

    When using this product

    • Use only as directed
    • Avoid contact with eyes and mucous membranes
    • Do not apply to wounds or damaged skin
    • Do not bandage tightly or use a heating pad

    Stop use and ask a doctor if

    • Excessive irritation or redness is present
    • Condition worsens
    • Pain persists for more than 7 days
    • Symptom clear up and occur again within a few days

    Do not use

    • With other creams, ointments, sprays, liniments, or other topical products containing menthol.

    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: Gently fold patch in half and remove one side of backing. Apply exposed adhesive to the site of pain. Remove remaining film from the other side and finish applying to skin. Use on affected areas for up to 12 hours. Children 12 years of age or younger: Consult a doctor

  • Other Information

    Store in a cool & dry place. Protect from excessive moisture. Do not refrigerate or freeze.

  • Inactive Ingredients

    Glyceryl Hydrogenated Rosinate, Mineral Oil, Styrene/Isoprene Copolymer

  • Questions or Comments

    Call +91 9212228401

  • SPL UNCLASSIFIED SECTION

    Manufactured By:

    UNEXO LIFE SCIENCES PVT. LTD.
    B-16. Sector 4, Bawana Industrial Area,
    Delhi – 110039 (INDIA)

  • PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box

    NDC: 71391-128-05

    MENTHOL 7.5% PATCH

    COOLING PAIN RELIEF PATCH
    WITH 7.5% NATURAL MENTHOL

    Backaches, Sore Muscles & Joint Pain
    Fast Acting Cooling Relief

    5 PATCHES
    5.51" X 3.94"
    (14cm X 10cm)

    PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box
  • INGREDIENTS AND APPEARANCE
    MENTHOL 
    menthol, unspecified form patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM105 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCEROL ESTER OF HYDROGENATED ROSIN (UNII: XH62RP786N)  
    Mineral Oil (UNII: T5L8T28FGP)  
    STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71391-128-011 in 1 POUCH; Type 0: Not a Combination Product11/15/2022
    2NDC:71391-128-055 in 1 BOX11/15/2022
    2NDC:71391-128-011 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34811/15/2022
    Labeler - Unexo Life Sciences Private Limited (872260479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences Private Limited872260479MANUFACTURE(71391-128)
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!