ENDOXCIN- lidocaine hydrochloride and menthol patch 
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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Endoxcin ​®

DRUG FACTS:

ACTIVE INGREDIENTS:

Lidocaine HCL 4.00%

Menthol 1.00%

Topical Anesthic

External Analgesic

USES:

For temporary relief of pain assoicated 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 symptons 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), Amica Montana Extract, Boswella Serrata Extract, Cameillia 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. Avoid direct sunlight.

Package Label

Endoxcin ​®​

(Lidocain 4% / Menthol 1%)

NDC: 45861-0006-15

Patch Size 12.5 x 8.5cm

Manufactured For: Pharmaceutica North America, Inc.

Glendale, CA 91205

For Questions or Comments please call 877-328-2592

Made in China • Patent Pending

Front Label

Back Label

ENDOXCIN 
lidocaine hydrochloride and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45861-006
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
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45861-006-3030 in 1 PACKAGE05/05/201401/01/2018
117 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:45861-006-1515 in 1 PACKAGE05/05/201401/01/2018
217 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/05/201401/01/2018
Labeler - Pharmaceutica North America, Inc. (962739699)

Revised: 2/2019
Document Id: 812b3b8b-5b4a-dd2e-e053-2991aa0a8c09
Set id: fd3f9e18-622a-400c-9665-bd2180a309ec
Version: 3
Effective Time: 20190205
 
Pharmaceutica North America, Inc.