Lidonexe Patch

Manufacturer: Patchwerx Labs, Inc.
Effective date: 2014-11-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:40:50

Label at a glance#

ProductLidonexe

Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL

Label structure7 sections

Indications and uses

For temporary relief of pain associated with minor cuts, scrapes and minor skin irritations.

Dosage and 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.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4.00%

Menthol 1.00%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

External Analgesic

Uses:

INDICATIONS & USAGE SECTION

For temporary relief of pain associated with minor cuts, scrapes and minor skin irritations.

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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.

Lidonexe 25 patches (69329 -002-25)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lindonexe_label_small.jpg

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1373130	Lidocaine/Menthol (Topical)	lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1373130	lidocaine HCl 4 % / menthol 1 % Medicated Patch	PSN	1
1373130	lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch	SCD	1
1373130	lidocaine HCl 4 % / menthol 1 % Medicated Patch	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0349430017159	GTIN-13: 0349430017159 EAN-13: 0349430017159 GTIN-12: 349430017159 UPC-A: 349430017159 GTIN storage (14 digits): 00349430017159	lindonexe_label_small.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69329-002-05	2020-01-31	C162847	48780-1	9d75b9d0-e9ec-f424-e053-dadaa90a57ce	Lidonexe Patch
69329-002-25	2020-01-31	C162847	48780-1	9d75b9d0-e9ec-f424-e053-dadaa90a57ce	Lidonexe Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69329-002-05	Lidonexe	10 g in 1 PATCH	PATCH	10	1
69329-002-05	Lidonexe	5 in 1 BOX	PATCH	5	1
69329-002-25	Lidonexe	25 in 1 BOX	PATCH	25	1
69329-002-25	Lidonexe	10 g in 1 PATCH	PATCH	10	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69329-002	LIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]	1	Legacy NDC, 4 package rows	20141118_081c276b-f715-081e-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
ARNICA MONTANA	INACTIVE INGREDIENT	O80TY208ZW	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	1
INDIAN FRANKINCENSE	INACTIVE INGREDIENT	4PW41QCO2M	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

Lidonexe
LIDOCAINE, MENTHOL
INDIAN FRANKINCENSE
LIDOCAINE HYDROCHLORIDE
LIDOCAINE
LIDOCAINE HYDROCHLORIDE ANHYDROUS
MENTHOL
GREEN TEA LEAF
ETHYLHEXYLGLYCERIN
GLYCERIN
ISOPROPYL MYRISTATE
POLYETHYLENE GLYCOL 400
PHENOXYETHANOL
POLYSORBATE 80
SODIUM LAURYL SULFATE
TROLAMINE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
ARNICA MONTANA
ALOE VERA LEAF
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69329-002	69329-002-05, 69329-002-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
INDIAN FRANKINCENSE	4PW41QCO2M	IACT
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR
MENTHOL	L7T10EIP3A	ACTIB
GREEN TEA LEAF	W2ZU1RY8B0	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
TROLAMINE	9O3K93S3TK	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
ARNICA MONTANA	O80TY208ZW	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
water	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 336 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, EXTENDED RELEASE / ORAL	2.03 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAMUSCULAR	20.3 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / AURICULAR (OTIC)	0.2 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TRANSDERMAL		113 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / TOPICAL		6300 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / OPHTHALMIC		46 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	DROPS / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRASYNOVIAL	0.2 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OINTMENT / TOPICAL	35 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / BUCCAL	0.11 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / TOPICAL		213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVITREAL	0.02 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / TOPICAL		34050 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / RECTAL	0.01 %w/v		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPRAY, METERED / NASAL		320 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / VAGINAL	0.4 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
081c276b-f716-081e-e054-00144ff88e88			081c276b-f715-081e-e054-00144ff88e88	2014-11-18	Warnings	Exact identifier spl id: 081c276b-f716-081e-e054-00144ff88e88 spl set id: 081c276b-f715-081e-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.