Label: PAIN RELIEF (menthol, unspecified form, methyl salicylate, and camphor- synthetic patch

  • 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 12, 2021

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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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