LIDONEXE- lidocaine, menthol patch

Lidonexe by

Drug Labeling and Warnings

Lidonexe by is a Otc medication manufactured, distributed, or labeled by Patchwerx Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

• 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), 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)

INGREDIENTS AND APPEARANCE

LIDONEXE 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69329-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69329-002-05	5 in 1 BOX
1		10 g in 1 PATCH
2	NDC: 69329-002-25	25 in 1 BOX
2		10 g in 1 PATCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/10/2014

Labeler - Patchwerx Labs, Inc. (079584480)