Salonpas Pain Relieving Lidocaine 4% Flex Patch
FDA Label NDC 46581-840

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hisamitsu Pharmaceutical Co., Inc. for the product Salonpas Pain Relieving Lidocaine 4% Flex (NDC 46581-840). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For temporary relief of pain

Warnings

For external use only

Do Not Use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any igredients of this product

When Using This Product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If Pregnant Or Breast-Feeding,

ask a health 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 of age and over:

  • clean and dry affected area
  • peel film from patch and apply to the skin (see illustration)
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

    • Children under 12 years of age: consult a doctor

Other Information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients

aluminum silicate, mineral oil, polyisobutylene, propylene glycol, styrene-isoprene-styrene block copolymer, terpene resin

Questions Or Comments?

Toll free 1-800-826-8861   www.salonpas.us

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NEW!

Hisamitsu
NDC#46581-840-07

for temporary relief of pain

PATCH CONTOURS TO YOUR BODY

Adheres as you move, bend, twist, or flex

Salonpas Pain Relieving FLEX Patch LIDOCAINE 4%

APPLY FOR UP TO 8 HOURS

MAXIMUM OTC STRENGTH

  • Stretchable
  • Thin Fabric
  • Strong Adhesion

    • 7 PATCHES
    2 3/4" X 3 15/16" (7cm X 10cm)

    MADE IN JAPAN

    Image Of 7-patch Box Label (4658184007 1)

    Image Of 7-patch Box Label (4658184007 1)

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