Lidothal Relief
FDA Label NDC 69561-463

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Henan Kangdi Medical Devices Co. Ltd. for the product Lidothal Relief (NDC 69561-463). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Menthol  1.00%

Lidocaine 4.00%

Otc - Purpose

Purpose

External analgesic

External analgesic

Indications & Usage

Uses:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains,

bruises and sprains

Warnings

Warnings:

  • For external use only
  • Avoid contact with eyes
  • Do not apply to open wounds or damages skin
  • If symptoms persist for more than seven days, discontinue use and consult physician
  • Keep out of reach of children. If swallowed, consult physician.
  • Do not bandage tightly
  • If pregnant or breast feeding, contact physician prior to use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, consult physician.

Dosage & Administration

Directions:

  • Clean and dry affected area
  • Remove patch from backing and apply to affected area. Apply directly to affected area.
  • Use only on patch at a time, and a maximum of four patches per day.
  • Leave patch of affected area for up to eight hours.
  • Do not use patches for more than five consecutive days
  • Children under 12 should consult a physician prior to use.

Storage And Handling

Store at room temperature. Avoid direct sunlight.

Inactive Ingredient

Other Ingredients:

acrylic acid ,aluminum hydroxide . carmellose sodium 2-ethylexyl acrylate glycerin . isopropyl myristate .methyl acrylate

nonoxynol-30 .poluacrylate.polyacrylic acid .polysorbate 80 sorbitan sesquioleate strach .talc .tartaric acid

.titanium dioxide .water(254-114)

Package Label.Principal Display Panel

Image Description (Lido 15)

Image Description (Lido 15)

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