LENZAGEL- lidocaine hydrochloride, menthol gel
Proficient Rx LP

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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LenzaGel

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

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

•: Apply directly to effected area. Do not use more than four times per day.

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.

LenzaGel 120g (63187-161-72)

LENZAGEL
lidocaine hydrochloride, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-161(NDC:45861-016)
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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	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:63187-161-72	120 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/01/2013	12/31/2020

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-161) , RELABEL(63187-161)

Revised: 1/2021

Document Id: 6834737d-b0b4-46bd-8b10-a4b1b476e0f6

Set id: 7f7eedea-0723-4e8f-a250-4c786aeb95e8

Version: 3

Effective Time: 20210101

Proficient Rx LP