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Lidozen by Village Pharma, LLC

Medically reviewed on August 2, 2017

Dosage form: patch
Ingredients: LIDOCAINE HYDROCHLORIDE 40mg in 1g, MENTHOL 10mg in 1g
Labeler: Village Pharma, LLC
NDC Code: 71574-400

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 Patch

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):

Clean and dry affected area.

Remove patch from backing and apply to affected area.

Use only one patch at a time, and maximum of four patches / day.

Leave patch on affected area for up to 8-hours.

Do not use patches for longer than five consecutive days.

Children under 12 should consult physician prior to use.

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

Store below 25 degrees Celsius. Avoid direct sunlight.

Package Labeling:

LIDOZEN 
lidocaine hydrochloride, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE40 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
ARNICA MONTANA 
INDIAN FRANKINCENSE 
GREEN TEA LEAF 
CARBOXYPOLYMETHYLENE 
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:71574-400-055 PATCH in 1 BOX
117 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/29/2017
Labeler - Village Pharma, LLC (080749749)

 
Village Pharma, LLC

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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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