Lidoflect Patch
FDA Label NDC 72835-404

8 label sections · Submitted to the FDA by V2 Pharma Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by V2 Pharma Llc for the product Lidoflect (NDC 72835-404). 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 lidoflect, active ingredients, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Lidoflect

Lidocaine 4% Patch

Flexible, elongated configuration

20 pre-cut patches on 1 roll

Active Ingredients

Lidocaine 4%

Purpose

Topical analgesic

Use

For the temporary relief of pain

Warnings

For external use only

When using this product

  • use only as directed. Read and follow all directions and warnings on this carton
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes
  • do not use at the same time as other topical analgesics
  • do not remove when wet, or directly after shower. Allow patch to dry and slowly remove

    • Stop use and ask a doctor if
    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling or blistering where the patch was applied

    • If pregnant or breast-feeding, ask a health professional before use
    • If swallowed, get medical help or contact a Poison Control Center right away

Otc - Keep Out Of Reach Of Children

• If swallowed, get medical help or contact a Poison Control Center right away

Directions

adults and children over 12 years:

  • Apply one patch to the affected area.
  • Wear for up to 12 hours, then remove before applying a new patch.
  • Store in a cool dry place in a resealable bag 
  • children 12 years or younger: ask a doctor

Inactive Ingredients

Acrylic adhesive, Linseed oil, and Polysorbate 80

* Please review the disclaimer below.