Sinsinpas Lidocaine Pain Relieving Patch
FDA Label NDC 55264-106

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sinsin Pharmaceutical Co., Ltd. for the product Sinsinpas Lidocaine Pain Relieving (NDC 55264-106). 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, keep out of reach of children or pets, uses, warnings, directions, inactive ingredients, sinsinpas lidocaine pain relieving patch, 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 Analgesic

Keep Out Of Reach Of Children Or Pets

Keep out of reach of children or pets.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)

Uses

For the temporarily relief of minor pain

Warnings

For external use only



Do not use

  • more than 1 patch at a time
  • on broken, irritated, or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

    • When using this product

    • use only as directed. Read and follow all direction and warning on this label
    • Avoid contact with the eyes or mucous membranes
    • Do not apply to broken, damaged, or irritated skin
    • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • Rare cases of serious burns have been reported with products of this type
    • Do not use with other topical analgesics
    • Keep children and pets away from used or disposed patch.
    • Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this product.

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove film from patch by gently pulling apart from corner
  • carefully apply to afftcted area
  • once patch is positioned, press firmly to adhere to skin
  • use only one patch at a time for up the 12 hours

    • Children undress 12 years of age: consult a professional

Inactive Ingredients

butylated hydroxytoluene
carboxymethylcellulose sodium
glycerin
edetate disodium
isopropyl myristate
kaolin
magnesium aluminosilicate
methyl acrylate and 2-ethylhexyl acrylate copolymer aqueous emulsion (mixture)
methyl paraben
polyacrylic acid
polysorbate 80
propylene glycol
propyl paraben
purified water
sodium polyacrylate
sorbitan sesquioleate
tartaric acid
urea

* Please review the disclaimer below.