Label: COMFORTE MENSTRUAL CRAMP RELIEF CREAM- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • Drug Facts

  • Active ingredient

    Menthol 4%

    Purpose

    Topical analgesic

  • Uses

    Temporarily relieves minor pain associated with cramps

  • Warnings

    For external use only

    if prone to allergic reaction from aspirin or salicylates, consult a doctor before use Allergy alert:

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs.

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes or mucuous membranes
    • do not apply to wounds or damaged skin.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away

  • Directions

    adults and children over 12 years: 

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin 
    • repeat as necessary, but no more than 4 times daily 
    • ask a doctor children 12 years or younger;
  • Inactive ingredients

    Shea Butter, Carapa Procera Oil, Sunflower Oil, Lavendar Oil, Calotropis Procera Extract, Sandalwood Oil, Red Cabbage Juice, Turmeric,  Monoglyceride, Diglyceride

  • Questions?

    Call 877.590.6257

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    COMFORTE MENSTRUAL CRAMP RELIEF CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73603-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SANDALWOOD OIL (UNII: X7X01WMQ5F)  
    TURMERIC (UNII: 856YO1Z64F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73603-000-001 in 1 BOX02/01/2023
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/01/2023
    Labeler - PMS4PMS LLC (117393964)
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