Painbloc24 Flexi-stretch Pain Tape
FDA Label NDC 71226-002

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 Flexi-stretch Pain Tape (NDC 71226-002). 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 active ingredients, purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients, label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

For Temporary Relief of Pain.

Warnings

For external use only

Do not use:

  •  more than 3 strips at a time
  • on damaged, broken or irritated skin
  •  with a heating pad
  •  if you are allergic to any of the ingredients in this product

    • When using this product use only as directed:

    •  do not bandage tightly
    •  avoid contact with eyes and mucous membranes
    •  dispose of used strips in a manner that keeps them away from children or pets so they are not accidentally ingested or chewed


      • Stop use and ask a doctor if:

      •  condition worsens
      •  redness or irritation develops
      •  you experience localized skin reactions such as rash, itching, pain, swelling or blistering
      •  symptoms last more than 7 days or clear up and occur again within a few days

        • 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 and Children 12 years and older

  •  Clean and dry affected area
  •  Trim excessive hair for better adhesion
  •  Remove roll from container and remove outer wrap
  •  Tear off 1 or 2 strips from roll. See illustration for instructions on removing the backing and applying to skin.
  •  Apply no more than 3 strips at a time, no more than 2 times a day
  •  Some individuals may not experience pain relief until several minutes or hours after applying
  •  Seal remaining roll with resealable tab, return to container and close cap securely
  •  Use strip as needed for up to 12 hours. Do not remove when wet or directly after showering or bathing. Allow strip to dry and then remove.

    • Children under 12 years: consult a doctor

Inactive Ingredients

aloe barbadensis leaf juice, arnica montana flower extract, boswellia, calendula,lavender, methylsulfonylmethane (MSM polysorbate 80, potassium sorbate, puri°edwater USP, sodium benzoate, tocopheryl acetate (vitamin E), water based acrylic adhesive, white curcumin.

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