Label: PAINBLOC24 PROWOMEN WOMENS DISCOMFORTS MENTHOL PAIN AND SLEEP PATCH- menthol 6% patch

  • Category: HUMAN OTC DRUG LABEL

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 10, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol unspecified 6%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • Simple backache
    • Muscle strains
    • Arthritis
    • Bruises
    • Sprains
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • consult your doctor before use if using any medications or supplements that contain any of these same ingredients
    • do not bandage tightly
    • do not use with heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds, damaged, broken or irritated skin
    • do not use at the same time as other topical analgesics

    Stop use and ask a doctor if

    • condition worsens
    • redness persists, spreads or becomes tender
    • symptoms last more than 7 days or clear up and occur again within a few days
    • you experience burning swelling or blistering where applied

    If pregnant or breast-feeding, ask a healthcare professional before use.

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

  • Directions

    Adults over 18 years:

    • clean and dry affected area
    • trim excessive hair for better adhesion
    • open pouch and remove patch
    • remove backing from patch by grasping both ends and pulling backing apart
    • peel off one half of backing and place patch onto affected area
    • peel off other half of backing and press and smooth onto skin
    • use patch as needed for up to 8 hours. Do not remove when wet or directly after showering or bathing. Allow patch to dry and then slowly remove.
    • use one patch at a time for up to 8 hours

    Children under 18 years: consult a doctor

  • Inactive Ingredients

    Acrylic adhesive, arnica montana flower extract, chamomile, d-limonene, dipropylene glycol, gamma-aminobutyric acid (GABA), hemp oil, l-theanine, lavender, magnesium chloride, melatonin, passionflower, polysorbate 80, tocopheryl acetate (Vitamin E), white curcumin

  • Questions

    Call 855-438-3944

  • Other Information

    Store in a cool, dry place at room temperature

  • Product label

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  • INGREDIENTS AND APPEARANCE
    PAINBLOC24 PROWOMEN WOMENS DISCOMFORTS MENTHOL PAIN AND SLEEP PATCH 
    menthol 6% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71226-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CHAMOMILE (UNII: FGL3685T2X)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    THEANINE (UNII: 8021PR16QO)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    MELATONIN (UNII: JL5DK93RCL)  
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CURCUMIN (UNII: IT942ZTH98)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71226-004-011 in 1 CARTON01/25/2022
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/25/2022
    Labeler - VIZURI HEALTH SCIENCES LLC (052129499)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shawsheen Rubber Co.001051275manufacture(71226-004)
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