LIDENZA PATCH- lidocaine hydrochloride patch

Lidenza Patch by

Drug Labeling and Warnings

Lidenza Patch by is a Prescription medication manufactured, distributed, or labeled by Patchwerx Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only

Avoid contact with eyes

Do not applly to open wounds or damaged skin

If symptoms persist for more than seven days, discontinue use and consult physician

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

ACTIVE INGREDIENT

Lidocaine HCL 4.00%

Menthol 1.00%

INACTIVE INGREDIENT

aloe barbadensis leaf, water, arnica montan extract, boswella serrata extract, camelia sinensis leaf extract, carbomer, ethylhexylglycerine, glycerine, isopropyl myristate, PEG 8, phenoxyethanol, polysorbate 80, sodium lauryl sulfate, triethanolamine, fd&c blue #1, fd&c yellow #5

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations

PURPOSE

Topical anesthetic

External analgesic

Lidenza Patch

INGREDIENTS AND APPEARANCE

LIDENZA PATCH 
lidocaine hydrochloride patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69329-017(NDC: 49430-017)
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ARNICA MONTANA (UNII: O80TY208ZW)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER 1342 (UNII: 809Y72KV36)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-8 GLYCERYL ISOSTEARATE (UNII: 74QQ5X3KL1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69329-017-15	100 g in 1 PACKAGE
2	NDC: 69329-017-25	100 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2013

Labeler - Patchwerx Labs, Inc. (079584480)