Label: MENTHOL 5% HYDROGEL- menthol, unspecified form patch

  • NDC Code(s): 71391-127-05
  • 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 January 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical Analgesic

  • Use

    For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps

  • Warnings

    For external use only

    When using this product

    • Use only as directed
    • Rare cases of serious burns have been reported with products of this type
    • Don't bandage tightly or use with a heating pad
    • Avoid contact with eyes or mucous membranes
    • Don't apply to wounds or damaged skin
    • Do not use at the same time as other topical analgesics

    Stop use and consult 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
    • You experience signs of skin injury such as pain, swelling, or blistering where the product was applied.

    If pregnant of breastfeeding, ask a health professional before use

    Keep Out of Reach of Children. Do not use on infants. If swallowed, seek medical help or contact a Poison Control Centre right away.

  • Directions

    • Adults and children 12 years of age and over: Carefully remove backing from patch. Applu sticky side of patch to affected area. Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age consult a physician.
  • Other Information

    Store at room temperature below 86°F (30°C)

  • Inactive Ingredients

    acrylates copolymer, alcohol, carboxymethylcellulose sodium, edetate Disodium, dihydroxyaluminium aminoacetate, glycerine, kaolin, methylparaben, polysorbate 80, polyvinyl alcohol, propylparaben, PVP, sodium polyacrylate, sorbitan oleate, sorbitol, tartaric Acid, titanium Dioxide, water

  • SPL UNCLASSIFIED SECTION

    Manufactured in India By:
    Unexo Life Sciences Pvt. Ltd.
    B-16, Sector 4, Bawana Industrial Area,
    Delhi - 110039 (INDIA)

  • PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Carton

    NDC 71391-127-05

    UNEXO'S MENTHOL 5%
    HYDROGEL PATCH

    5% Menthol

    BACK & LARGE AREAS

    Targeted, Long-Lasting
    Pain Relief

    TOPICAL ANALGESIC

    • Adhesive Fabric Patch
    • No-Mess Application
    • Single Use

    5
    PATCHES
    7.87 IN. X 3.93 IN. (20 cm × 10 cm)

    Compare to Extra Strength
    Icy Hot® Medicated Patch
    active ingredient*

    PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Carton
  • INGREDIENTS AND APPEARANCE
    MENTHOL 5% HYDROGEL 
    menthol, unspecified form patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM600 mg
    Inactive Ingredients
    Ingredient NameStrength
    Butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 MW) (UNII: JZ1374NL9E)  
    Alcohol (UNII: 3K9958V90M)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    Edetate disodium (UNII: 7FLD91C86K)  
    Dihydroxyaluminum aminoacetate (UNII: DO250MG0W6)  
    Glycerin (UNII: PDC6A3C0OX)  
    Kaolin (UNII: 24H4NWX5CO)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Polyvinyl alcohol, unspecified (UNII: 532B59J990)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Povidone, unspecified (UNII: FZ989GH94E)  
    Sodium polyacrylate (2500000 MW) (UNII: 05I15JNI2J)  
    Sorbitan monooleate (UNII: 06XEA2VD56)  
    Sorbitol (UNII: 506T60A25R)  
    Tartaric acid (UNII: W4888I119H)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71391-127-055 in 1 POUCH; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/01/2020
    Labeler - Unexo Life Sciences, Private Limited (872260479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences, Private Limited872260479MANUFACTURE(71391-127)
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