LIDOZEN- lidocaine hydrochloride, menthol patch

Lidozen by

Drug Labeling and Warnings

Lidozen by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

ACTIVE INGREDIENTS:

Lidocaine HCL 4.00%

Menthol 1.00%

Toplcal 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 consective days.

Children under 12 should consult physician prior to use.

INACTIVE INGREDIENTS:

Propylene Glycol, Carboxymethyl Cellulose Sodium, Dihydroxyaluminum Aminoacetate, Ethanol, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Polysorbate 80, Polyvinylpyrrolidone 90, Tartaric Acid, Tetrasodium Edetate, Titanium Dioxide, Hydrogenated Castor Oil, Phenoxyethanol, Urea, Water.

SPL UNCLASSIFIED SECTION

Store below 25 degrees Celsius. Avoid directed sunlight.

Package Labeling:

INGREDIENTS AND APPEARANCE

LIDOZEN 
lidocaine hydrochloride, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-302(NDC:71574-800)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
EDETATE SODIUM (UNII: MP1J8420LU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71205-302-05	5 in 1 POUCH	08/01/2019
1		1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 71205-302-30	30 in 1 POUCH	08/01/2019
2		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2019

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(71205-302) , RELABEL(71205-302)