Lidenza Patch

LIDENZA PATCH- lidocaine hydrochloride and menthol patch
Patchwerx Labs, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

Lidocaine HCL 4.00%

Menthol 1.00%

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

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

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

Topical anesthetic

External analgesic

Lidenza Patch

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g
MENTHOL (MENTHOL) MENTHOL 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
ARNICA MONTANA
POLYSORBATE 80
ALOE VERA LEAF
BOSWELLIA SACRA WHOLE
GREEN TEA LEAF
CARBOMER 1342
ETHYLHEXYLGLYCERIN
ISOPROPYL MYRISTATE
PEG-8 GLYCERYL ISOSTEARATE
PHENOXYETHANOL
SODIUM LAURYL SULFATE
TRIETHANOLAMINE BENZOATE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69329-017-15 100 g in 1 PACKAGE None
2 NDC:69329-017-25 100 g in 1 PACKAGE None
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)

Revised: 11/2014 Patchwerx Labs, Inc.

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