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Lidothol Patch

Generic Name: lidocaine, menthol
Dosage Form: patch

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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.

INACTIVE INGREDIENTS:

ACRYLIC ACID, ALUMINUM HYDROXIDE, CARMELLOSE SODIUM, 2-ETHYLHEXYL ACRYLATE, GLYCERIN, ISOPROPYL MYRISTATE, METHYL ACRYLATE, NONOXYNOL-30, POLYACRYLIC ACID, POLYSORBATE 80, SORBITAN SESQUIOLEATE, STARCH, TALC, TARTARIC ACID, TITANIUM DIOXIDE, WATER.

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.

LIDOTHOL 
lidocaine, menthol patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53225-1025
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 5 g
LIDOCAINE (LIDOCAINE) LIDOCAINE 4.5 g
Inactive Ingredients
Ingredient Name Strength
ACRYLIC ACID  
ALUMINUM HYDROXIDE  
CROSCARMELLOSE SODIUM  
ETHYLHEXYL ACETATE  
GLYCERIN  
ISOPROPYL MYRISTATE  
METHYL ACRYLATE  
NONOXYNOL-30  
POLYACRYLIC ACID (8000 MW)  
POLYSORBATE 80  
SODIUM POLYACRYLATE (2500000 MW)  
SORBITAN SESQUIOLEATE  
STARCH, CORN  
TALC  
TARTARIC ACID  
TITANIUM DIOXIDE  
WATER  
Packaging
# Item Code Package Description
1 NDC:53225-1025-1 15 PATCH in 1 BOX
1 NDC:53225-1025-0 1 PATCH in 1 PATCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/16/2015
Labeler - Terrain Pharmaceuticals (078358750)
Revised: 11/2015
 
Terrain Pharmaceuticals



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