Label: MENTHOL 5%- menthol, unspecified form patch

  • NDC Code(s): 71391-123-18, 71391-123-36
  • Packager: Unexo Life Sciences, Private Limited
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 10, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 5% - Topical Analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with:

    • Simple backache
    • Arthritis
    • Sprains
    • Strains
    • Bruises
  • Warnings

    For external use only

    Do not use

    • On wounds or damaged skin
    • With a heating pad

    Ask a doctor before use if you have

    • Redness over affected area

    When using this product

    • Avoid contact with eyes and mucous membranes
    • Do not bandage tightly

    Stop use and ask a doctor if

    • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • Excessive skin irritation occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older apply to the affected area no more than 3 to 4 times daily
    • Open pouch & remove patch
    • Peel off protective film and apply sticky side to affected area
    • Children under 12 years of age consult a doctor
  • Inactive Ingredients

    Adhesive plaster, aloe extract, dl-camphor, purified lanolin, spearmint, titanium dioxide, zinc oxide

  • Questions

    Call 1-215-666-3200

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 1 Patch Pouch

    Lasts upto 8 Hours!

    MENTHOL 5%
    PATCH

    XL

    Pain Relief
    BACK
    PATCH
    5% Menthol

    Relieves Back Pain & Stiffness

    • Not Messy or Greasy
    • Comfortable, Breathable & Stays on Securely

    1 Extra Large
    Medicated Patch
    9 x 4 in (22 x 10 cm)

    PRINCIPAL DISPLAY PANEL - 1 Patch Pouch
  • INGREDIENTS AND APPEARANCE
    MENTHOL 5% 
    menthol, unspecified form patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM440 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    Camphor (synthetic) (UNII: 5TJD82A1ET)  
    Lanolin (UNII: 7EV65EAW6H)  
    Spearmint (UNII: J7I2T6IV1N)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Zinc Oxide (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71391-123-1818 in 1 BOX03/01/2018
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:71391-123-3636 in 1 BOX03/01/2018
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2018
    Labeler - Unexo Life Sciences, Private Limited (872260479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences, Private Limited872260479MANUFACTURE(71391-123)
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