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
  • 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 January 12, 2021

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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 not finalpart34803/01/2018
    Labeler - Unexo Life Sciences, Private Limited (872260479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences, Private Limited872260479MANUFACTURE(71391-123)
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