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:

Label

LIDOZEN
lidocaine hydrochloride, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71574-400
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71574-400-05	5 in 1 BOX	07/29/2017	07/30/2021
1		17 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	07/29/2017	07/30/2021

Labeler - Village Pharma, LLC (080749749)

Revised: 10/2023

Document Id: 071d124a-b535-339f-e063-6294a90a101c

Set id: 55c53f81-9418-33e1-e054-00144ff8d46c

Version: 6

Effective Time: 20231007

Village Pharma, LLC