LIDOZEN- lidocaine hydrochloride, menthol gel 
Proficient Rx LP

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Lidozen Gel

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):

Apply directly to affected area. Do not use more than four times per day.

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

Package Labeling:

63187-892-72

Manufactured for:

Village Pharma LLC

Agoura Hills, CA 91301

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

LIDOZEN 
lidocaine hydrochloride, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-892(NDC:71574-300)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE40 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63187-892-721 in 1 BOX08/01/2017
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:63187-892-642 in 1 BOX11/13/202011/30/2023
2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/22/2017
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022RELABEL(63187-892)

Revised: 11/2023
Document Id: de5d688d-8c71-4bf5-999c-17a3f323f854
Set id: 1ebb45e5-4541-4c95-abe1-661ef763a610
Version: 8
Effective Time: 20231101
 
Proficient Rx LP