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HOT COLD LIDOCAINE WITH MENTHOL

Medically reviewed on October 9, 2017.

Dosage form: patch
Ingredients: LIDOCAINE 40mg, MENTHOL 10mg
Labeler: Foshan Aqua Gel Biotech Co., Ltd.,
NDC Code: 69159-004

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.

HOT COLD LIDOCAINE WITH MENTHOL PATCH

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Lidocaine 4%

Menthol 1%

Purpose

Topical Anesthetic/ Analgesic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use
  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When Using This Product
  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop Use and Ask a Doctor if
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children and Pets

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Directions

Adults and children over 12 years:

  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

Dihydroxyaluminum aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic acid, Propylene glycol, Propylparaben, PVP, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Tween 80, Water

HOT COLD LIDOCAINE WITH MENTHOL 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69159-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE40 mg
MENTHOL (MENTHOL) MENTHOL10 mg
Inactive Ingredients
Ingredient NameStrength
DIETHYLENE GLYCOL MONOETHYL ETHER 
DIHYDROXYALUMINUM AMINOACETATE 
GLYCERIN 
KAOLIN 
POLYACRYLIC ACID (300000 MW) 
POVIDONE 
SODIUM POLYACRYLATE (2500000 MW) 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
PROPYLPARABEN 
POLYSORBATE 80 
Packaging
#Item CodePackage Description
1NDC:69159-004-01300 PATCH in 1 CASE
11 PATCH in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/11/2017
Labeler - Foshan Aqua Gel Biotech Co., Ltd., (529128763)

 
Foshan Aqua Gel Biotech Co., Ltd.,

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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