LENZAPATCH- lidocaine hydrochloride, menthol liquid
Pharmaceutica North America, Inc.

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.

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LenzaPatch

Active Ingredients:

Lidocaine HCL 4.00%

Menthol 1.00%

Purpose

Topical Analgesic

External Analgesic

Uses:

For temporary relief of pain associated with minor cuts, scrapes and minor skin irritations.

Warnings

For external use only
Avoid contact with eyes
Do not apply to open wounds or damaged skin.
If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not bandage tightly
If pregnant or breast feeding, contact physician prior to use.
Do not use in large quantities, particularly over raw surfaces or blistered areas.

Directions

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.

Other 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, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD C Blue 1, FD C Yellow 5.

Store below 25 degrees. Avoid direct sunlight.

LenzaPatch 5 patches (45861-017-05)

LENZAPATCH
lidocaine hydrochloride, menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45861-017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 100 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)
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:45861-017-05	5 in 1 BOX	03/01/2013	01/01/2018
1		17 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/01/2013	01/01/2018

Labeler - Pharmaceutica North America, Inc. (962739699)

Revised: 2/2019

Document Id: 812c4000-01db-cfa0-e053-2a91aa0aab51

Set id: dc50b0bf-5929-4497-85e8-1cb5aed67ad7

Version: 5

Effective Time: 20190205

Pharmaceutica North America, Inc.