LIDOZEN- lidocaine, menthol patch

Lidozen by

Drug Labeling and Warnings

Lidozen by is a Otc medication manufactured, distributed, or labeled by Village Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

ACTIVE INGREDIENTS:

Lidocaine 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:

Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben

SPL UNCLASSIFIED SECTION

Store below 25 degrees Celsius, Avoid directe sunlight.

Package Labeling:

INGREDIENTS AND APPEARANCE

LIDOZEN 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71574-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71574-900-05	5 in 1 POUCH	09/25/2019
1		1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/16/2019

Labeler - Village Pharma, LLC (080749749)