LIDONEXE- lidocaine, menthol patch 
Patchwerx Labs, 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.

----------

Lidonexe Patch

Lidonexe Patch


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

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

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.


Lidonexe 25 patches (69329 -002-25)

lindonexe_label_small.jpg

LIDONEXE 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69329-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
ARNICA MONTANA (UNII: O80TY208ZW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69329-002-055 in 1 BOX
110 g in 1 PATCH
2NDC:69329-002-2525 in 1 BOX
210 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/10/2014
Labeler - Patchwerx Labs, Inc. (079584480)

Revised: 11/2014
Document Id: 081c276b-f716-081e-e054-00144ff88e88
Set id: 081c276b-f715-081e-e054-00144ff88e88
Version: 1
Effective Time: 20141118
 
Patchwerx Labs, Inc.