1. Home
  2. Labeler Index
  3. Vizuri Health Sciences Llc
  4. 71226-002
  5. Label Information: Painbloc24 Flexi-stretch Pain Tape

FDA Label for Painbloc24 Flexi-stretch Pain Tape

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. LABEL

Painbloc24 Flexi-stretch Pain Tape Product Label

The following document was submitted to the FDA by the labeler of this product Vizuri Health Sciences Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


* Please review the disclaimer below.