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Lidocaine Patch

Medically reviewed on October 9, 2017

Dosage form: patch
Ingredients: LIDOCAINE 40mg
Labeler: Foshan Aqua Gel Biotech Co., Ltd.,
NDC Code: 69159-003

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.

Maximum Strength Lidocaine Patch- bulk label

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Lidocaine 4%

Purpose

Topical Anesthetic

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

Outer Label

LIDOCAINE PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69159-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE40 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM POLYACRYLATE (8000 MW) 
KAOLIN 
METHYLPARABEN 
PROPYLPARABEN 
POVIDONE 
DIHYDROXYALUMINUM AMINOACETATE 
GLYCEROL (1-(12-HYDROXYSTEARATE)) 
POLYACRYLIC ACID (250000 MW) 
TARTARIC ACID 
POLYSORBATE 80 
WATER 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:69159-003-01300 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.,

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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