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Endoxcin

Dosage form: patch
Ingredients: LIDOCAINE HYDROCHLORIDE 4g in 100g, MENTHOL 1g in 100g
Labeler: Pharmaceutica North America, Inc.
NDC Code: 45861-006

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.

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

ENDOXCIN 
lidocaine hydrochloride and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45861-006
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GREEN TEA LEAF 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
ISOPROPYL MYRISTATE 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
SODIUM LAURYL SULFATE 
TROLAMINE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:45861-006-3030 PATCH in 1 PACKAGE
117 g in 1 PATCH
2NDC:45861-006-1515 PATCH in 1 PACKAGE
217 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/05/2014
Labeler - Pharmaceutica North America, Inc. (962739699)

Revised: 12/2017
 
Pharmaceutica North America, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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