Label: MENTHOL CAMPHOR MICRO (menthol, unspecified form and camphor- natural patch

  • NDC Code(s): 71391-140-20, 71391-140-60
  • 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 October 26, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Camphor 7.0%Topical Analgesic
    Menthol 7.0%Topical Analgesic
  • Uses

    temporarily relieves minor pain associated with:

    • Arthritis
    • Simple backache
    • Muscle strains
    • Sprains
    • Bruises
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • Do not bandage tightly or use with a heating pad
    • Avoid contact with eyes and mucous membranes
    • Do not apply to wounds or damaged, broken or irritated skin
    • Do not use at the same time as other topical analgesics

    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 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 12 years:

    • clean and dry the affected area
    • apply to the affected area no more than 3 to 4 times daily
    • Use 1 patch for 8 to 12 hours, once per day

    Children under 12 years of age:

    • Ask a doctor
  • Other Information

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

    Adhesive plaster, eucalyptus globulus leaf oil, gaultheria fragrantissima (wintergreen) oil, clove (syzygium aromaticum) flower oil

  • Questions?

    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 - 60 Patch Pouch Box

    Lasts Up to 12 Hours!

    UNEXO'S MENTHOL
    CAMPHOR MICRO PATCH

    Pain Relief
    MICRO
    PATCH
    7% Menthol, 7% Camphor

    Deep Penetrating
    Targeted Pain Relief

    • Sweat Proof Technology
      to Stay in Place Securely
    • Lasts Up to 12 Hours

    60 Patches

    Medicated Patch
    2.55 x 1.65 in (65mm x 42mm)

    PRINCIPAL DISPLAY PANEL - 60 Patch Pouch Box
  • INGREDIENTS AND APPEARANCE
    MENTHOL CAMPHOR MICRO 
    menthol, unspecified form and camphor (natural) patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM38.22 mg
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)38.22 mg
    Inactive Ingredients
    Ingredient NameStrength
    Eucalyptus oil (UNII: 2R04ONI662)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Clove Oil (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71391-140-201 in 1 BOX11/15/2021
    120 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:71391-140-603 in 1 BOX11/15/2021
    220 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2021
    Labeler - Unexo Life Sciences Private Limited (872260479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences Private Limited872260479MANUFACTURE(71391-140)
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