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Maximum strength Lidocaine Patch

Dosage form: patch
Ingredients: LIDOCAINE 40mg
Labeler: Velocity Pharma LLC
NDC Code: 76168-067

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

Active ingredient

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

Inactive Ingredients

aluminium hydroxide gel, bentonite, borax, carbomer, carboxymethylcellulose sodium,
colloidal silicon dioxide, dihydroxyaluminumaminoacetate, disodiumedetate, gelatin, glycerin, oleic acid, polysorbate 80, polyvinyl Alcohol, potassium Sorbate, povidone, propylene glycol, sodiummetabisulphite, tartaric acid, trolamine, urea, water

Package/Label Principal Display Panel

MAX STRENGTH LIDOCAINE PATCH

-NUMBS AWAY PAIN

MAXIMUM STRENGTH LIDOCAINE PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-067
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE40 mg
Inactive Ingredients
Ingredient NameStrength
ALGELDRATE 
BENTONITE 
CARBOMER 940 
CARBOXYMETHYLCELLULOSE SODIUM 
DIHYDROXYALUMINUM AMINOACETATE 
EDETATE DISODIUM ANHYDROUS 
GELATIN 
GLYCERIN 
OLEIC ACID 
POLYSORBATE 80 
POLYVINYL ALCOHOL, UNSPECIFIED 
POTASSIUM SORBATE 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM METABISULFITE 
SILICON DIOXIDE 
SODIUM BORATE 
TROLAMINE 
TARTARIC ACID 
UREA 
WATER 
Packaging
#Item CodePackage Description
1NDC:76168-067-115 POUCH in 1 CARTON
11 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/06/2017
Labeler - Velocity Pharma LLC (962198409)
Registrant - Velocity Pharma LLC (962198409)

Revised: 03/2017
 
Velocity Pharma LLC

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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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