Painbloc24 Prowomen Womens Discomforts Menthol Pain And Sleep Patch
FDA Label NDC 71226-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vizuri Health Sciences Llc for the product Painbloc24 Prowomen Womens Discomforts Menthol Pain And Sleep Patch (NDC 71226-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Image Description (Image 001)

Image Description (Image 001)

Image Description (Image 002)

Image Description (Image 002)

* Please review the disclaimer below.