PAIN RELIEF (MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND CAMPHOR (SYNTHETIC)) PATCH [UNEXO LIFE SCIENCES, PRIVATE LIMITED]

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  • PAIN RELIEF (MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND CAMPHOR (SYNTHETIC)) PATCH [UNEXO LIFE SCIENCES, PRIVATE LIMITED]

PAIN RELIEF (MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND CAMPHOR (SYNTHETIC)) PATCH [UNEXO LIFE SCIENCES, PRIVATE LIMITED]
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NDC 71391-135-03
Set ID b409dcf0-9309-490e-8ac2-9de81f006318
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

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Menthol 7%Topical Analgesic
    Wintergreen Oil 7%Topical Analgesic
    Camphor 7%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 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 of 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
    • Children under 12 years of age, consult a doctor
  • Other Information

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

    Adhesive Plaster

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 3 Patch Pouch

    NDC: 71391-135-03

    unexo®
    LIFE SCIENCES

    PAIN RELIEF PATCH
    MEDICATED | FAST ACTING

    Lower Back
    Joints
    Upper Back
    Shoulder
    Elbow

    APPLY FOR 8-12 HOURS

    3 PATCHES
    LARGE

    PLEASE RESEAL AFTER OPENING

    PRINCIPAL DISPLAY PANEL - 3 Patch Pouch
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    menthol, unspecified form, methyl salicylate, and camphor (synthetic) patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM78 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE78 mg
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)78 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71391-135-033 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(71391-135)
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