Label: FEMININE PAIN RELIEF- menthol, unspecified form patch

  • NDC Code(s): 71391-131-04, 71391-131-24
  • Packager: Unexo Life Sciences Private Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 8, 2024

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Uses

    For temporary relief of minor aches and pains in lower back and abdomen associated with cramps.

  • Active Ingredient

    Menthol 10%

  • Purpose

    Topical Analgesic

  • Warnings

    For External Use Only.

    Do not use otherwise than as directed.

    Do Not Use

    • On open wounds, cuts, eyes and face
    • With a heating pad

    When using this product

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

    Ask Your Doctor Before Use if you have

    • redness over the affected area
    • have sensitive skin
    • are pregnant or breast-feeding

    Stop Use and Ask Your Doctor

    • If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • If abnormal skin irritation occurs after usage

    Keep Out of Reach of Children.

    If swallowed, seek medical help or contact a Poison Control Center right away.

  • Directions

    • For use by Adults and Children 12 years of age and older
    • Apply to the affected area no more than 2 times a day
    • Dry skin completely at application area, before applying the patch
    • Open pouch and remove patch
    • Peel off protective film and apply sticky side to affected area
    • If applied on hairy skin, remove gently using mild warm water
    • Patch once used, cannot be re-pasted or reused
    • Dispose properly after use
  • Other Information

    • Store at room temperature below 80°F (27°C)
  • Inactive Ingredients

    Adhesive Plaster, Eucalyptus Oil

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Label

    NDC: 71391-131-04

    UNEXO LIFE SCIENCES

    FEMININE PAIN RELIEF PATCH
    50 cm2

    MENTHOL

    SOOTHE PERIOD CRAMPS
    FAST ACTING
    APPLY FOR 8-12 HOURS

    4 PATCHES

    PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Label
  • INGREDIENTS AND APPEARANCE
    FEMININE PAIN RELIEF 
    menthol, unspecified form patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    Eucalyptus oil (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71391-131-2424 in 1 BOX03/06/2024
    1NDC:71391-131-044 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01703/06/2024
    Labeler - Unexo Life Sciences Private Limited (872260479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences Private Limited872260479MANUFACTURE(71391-131)