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LenzaGel by Pharmaceutica North America, Inc.

Medically reviewed on December 28, 2017

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 4g in 100g, MENTHOL 1g in 100g
Labeler: Pharmaceutica North America, Inc.
NDC Code: 45861-016

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.

LenzaGel

LenzaGel


Active Ingredients:

Lidocaine HCL 4.00%

Menthol 1.00%


Purpose

Topical Analgesic

External Analgesic

Uses:

For temporary relief of pain associated with minor cuts, scrapes and minor skin irritations.

Warnings
  • For external use only
  • Avoid contact with eyes
  • Do not apply to open wounds or damaged 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.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.

Directions
  • Apply directly to effected area. Do not use more than four times per day.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD C Blue 1, FD C Yellow 5.

LenzaGel 120g (45861-016-01)
LENZAGEL 
lidocaine hydrochloride, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45861-016
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
ARNICA MONTANA 
INDIAN FRANKINCENSE 
GREEN TEA LEAF 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
ISOPROPYL MYRISTATE 
POLYETHYLENE GLYCOL 400 
PHENOXYETHANOL 
POLYSORBATE 80 
SODIUM LAURYL SULFATE 
TROLAMINE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:45861-016-01120 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2013
Labeler - Pharmaceutica North America, Inc. (962739699)

 
Pharmaceutica North America, Inc.

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Further information

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

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