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Lidothal Relief by Henan Kangdi Medical Devices Co. Ltd.

Medically reviewed on July 31, 2017

Dosage form: patch
Ingredients: MENTHOL 1g in 100g, LIDOCAINE 4g in 100g
Labeler: Henan Kangdi Medical Devices Co. Ltd.
NDC Code: 69561-463

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredient

Menthol  1.00%

Lidocaine 4.00%

Purpose

External analgesic

External analgesic

Uses:

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

bruises and sprains

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

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

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.

Store at room temperature. Avoid direct sunlight.

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)

LIDOTHAL RELIEF 
menthol, lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69561-463
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID 
ALUMINUM HYDROXIDE 
CROSCARMELLOSE SODIUM 
2-ETHYLHEXYL ACRYLATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
POLYACRYLAMIDE (10000 MW) 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:69561-463-1515 PATCH in 1 BOX
18.5 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/31/2017
Labeler - Henan Kangdi Medical Devices Co. Ltd. (421288241)

 
Henan Kangdi Medical Devices Co. Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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