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  5. Label Information: Lidothol

FDA Label for Lidothol

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES:
    4. DIRECTIONS
    5. INSTRUCTIONS FOR USE:
    6. INACTIVE INGREDIENTS:
    7. OTHER INFORMATION:
    8. WARNINGS:
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidothol Product Label

The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals Inc.. 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 4.5%

MENTHOL 5%


Purpose



TOPICAL ANESTHETIC

TOPICAL ANALGESIC


Uses:



TEMPORARILY RELIEVES MILD TO MODERATE ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH

  • •MUSCLE SORENESS
  • •STRAINS
  • •SPRAINS
  • •ARTHRITIS
  • •SIMPLE BACKACHE
  • •MUSCLE STIFFNESS
  • •BRUISES

Directions



ADULTS AND CHILDREN 12 YEARS AND OVER: APPLY 1 TO 2 PATCHES TO AFFECTED AREA ONCE PER DAY. LIDOTHOL PATCHES SHOULD BE WORN FOR NO MORE THAN 12 HOURS WITHIN A 24 HOUR PERIOD.


Instructions For Use:



  • •CLEAN AND DRY AFFECTED AREA
  • •OPEN POUCH AND REMOVE ONE POUCH
  • •REMOVE PROTECTIVE FILM FROM POUCH
  • •APPLY ONE PATCH TO THE AFFECTED AREA OF PAIN AND LEAVE IN PLACE 8 TO 12 HOURS
  • •USE ONLY ONE PATCH AT A TIME
  • •DO NOT USE MORE THAN 2 PATCHES PER DAY
  • •WASH HANDS WITH SOAP AND WATER AFTER APPLYING OR REMOVING PATCH
  • •RESEAL POUCH CONTAINING UNUSED PATCHES AFTER EACH USE.

Other Information:



  • •SOME INDIVIDUALS MAY NOT EXPERIENCE PAIN RELIEF UNTIL SEVERAL MINUTES OR HOURS AFTER APPLYING THE PATCH.
  • •AVOID STORING PRODUCTS IN DIRECT SUNLIGHT.
  • •PROTECT PRODUCT FROM EXCESSIVE MOISTURE.
  • •STORE BELOW 90°F/32°C

Warnings:



For external use only. Use only as directed or under supervision of a licensed healthcare professional.

Do not use:

  • •on the face or rashes
  • •on wounds, damaged, or infected skin
  • •in the eyes, mouth, or other mucous membranes
  • •on genitals
  • •with a heating pad
  • •any patch from a pouch that has been opened for 7 or more days

    • Ask a doctor befire use if:

    • •you are allergic to topical products or any ingredients in this product
    • •you are pregnant or breast feeding
    • •you are under age 18

      • When using this product:

      • •wash hands after applying or removing patch. Avoid contact with eyes. if eye contact occurs, rinse thoroughly with water.

        • Stop use and consult your physician if:

        • •rash, irritation, or itching develops
        • •condition worsens

          • Keep out of reach of children. If put in mouth, get medical help or contact a poison Control Center righ away. Package not child resistant. Dispose of the used pouches by folding sticky ends together. Duscard safely away from children or pets.


Package Label.Principal Display Panel



Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-7405-1


* Please review the disclaimer below.