Label: HEALTHWISE MENSTRUAL PAIN RELIEF PATCH- menthol 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 November 26, 2022

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  • Drug Facts

  • Active Ingredients (In each patch)

    Menthol 10.0%

  • Purpose

    Topical Analgesic

  • Uses

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

  • Warnings

    For external use only

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    When using this product

    • Use only as directed
    • Rare cases of serious burns have been reported with products of this type
    • Don't bandage tightly or use with heating pad
    • Avoid contact with the eyes, mucous membranes
    • Do not apply to wounds or damaged skin
    • Do not use at the same time as other topical analgesics.


    Stop using and consult 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
    • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

    If pregnant or breastfeeding

    as a health professional before use

    Keep out of reach of children

    Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • Directions

    Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Wear one patch up to 8-12 hours. Repeat as necessary, but no more than 2 times daily. Properly discard patch after single use. children under 12 years of age consult a physician.

  • Other Information

    Store at room temperature, not to exceed 80°F (27ºC)

  • Inactive Ingredients

    • adhesive plaster • eucalyptus oil

  • Questions?

    Call 1-866-326-1313

  • Packaging

    label

  • INGREDIENTS AND APPEARANCE
    HEALTHWISE MENSTRUAL PAIN RELIEF PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-947
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-947-1010 in 1 BOX11/01/2022
    11 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2022
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences, Private Limited872260479manufacture(71101-947)
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