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Lidozen by Village Pharma, LLC

Medically reviewed on August 10, 2017

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 40mg in 1mL, MENTHOL 10mg in 1mL
Labeler: Village Pharma, LLC
NDC Code: 71574-300

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.

Lidozen Gel

DRUG FACTS:

ACTIVE INGREDIENTS:

Lidocaine HCL 4.00%

Menthol 1.00%

Topical Anesthetic

External Analgesic

USES:

For temporary relief of pain

WARNINGS:
  • For external use only.
  • Avoid contact with eyes.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • ​If pregnant or breast-feeding,​ ask a health professional before use.

Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS (Adults and Children Over 12 Years):

Apply directly to affected area. Do not use more than four times per day.

INACTIVE 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, Polysorbte-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5

Package Labeling:

LIDOZEN 
lidocaine hydrochloride, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE40 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
ARNICA MONTANA 
INDIAN FRANKINCENSE 
GREEN TEA LEAF 
CARBOXYPOLYMETHYLENE 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
TROLAMINE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
ISOPROPYL MYRISTATE 
POLYETHYLENE GLYCOL 400 
PHENOXYETHANOL 
POLYSORBATE 80 
SODIUM LAURYL SULFATE 
Packaging
#Item CodePackage Description
1NDC:71574-300-721 BOTTLE in 1 BOX
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/22/2017
Labeler - Village Pharma, LLC (080749749)

 
Village 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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