FEMININE PAIN RELIEF (MENTHOL, UNSPECIFIED FORM) PATCH [UNEXO LIFE SCIENCES, PRIVATE LIMITED]

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FEMININE PAIN RELIEF (MENTHOL, UNSPECIFIED FORM) PATCH [UNEXO LIFE SCIENCES, PRIVATE LIMITED]
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NDC 71391-130-05
Set ID 30d6241f-9fca-4a1a-a509-1274007debb3
Category HUMAN OTC DRUG LABEL
Packager Unexo Life Sciences, Private Limited
Generic Name
Product Class
Product Number
Application Number PART348
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  • 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 - 5 Patch Pouch

    PLEASE RESEAL AFTER OPENING

    NDC: 71391-130-05

    unexo®
    LIFE SCIENCES

    FEMININE
    PAIN RELIEF
    PATCH

    PACK OF
    5
    PATCHES

    SOOTHE
    PERIOD CRAMPS

    MEDICATED PATCH
    FAST ACTING
    APPLY FOR 8-12 HOURS

    Principal Display Panel - 5 Patch Pouch
  • INGREDIENTS AND APPEARANCE
    FEMININE PAIN RELIEF 
    menthol, unspecified form patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM200 mg
    Inactive Ingredients
    Ingredient NameStrength
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71391-130-055 in 1 POUCH; Type 0: Not a Combination Product01/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/19/2019
    Labeler - Unexo Life Sciences, Private Limited (872260479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences, Private Limited872260479MANUFACTURE(71391-130)
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