Lidocaine 5%

Manufacturer: TriMarc Labs
Effective date: 2021-12-10
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:23:31

Label at a glance#

ProductLidocaine 5%

Active ingredientLIDOCAINE

Label structure8 sections

Dosage and administration

When practical, clean area with mild soap and warm water and rinse thouroughly Gently dry by patting or blotting with toilet tissue or soft cloth before applying Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day. Children under 12 years of age: Consult a doctor

Storage and handling

Store at 25 deg. C (77F); excursions permitted to 15-30 deg. C (59-86F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to anorectal disorders

WARNINGS:

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes
do not use in large quantities, particularly over raw surfaces or blistered areas
do not put directly in rectum by using fingers or mechanical device
do not exceed recommended dosage unless directed by a doctor

Stop use and ask doctor if:

OTC - ASK DOCTOR SECTION

allergic reaction occurs
rectal bleeding occurs
condition worsens or does not improve within 7 days
symptoms clear up and return within a few days
redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

When practical, clean area with mild soap and warm water and rinse thouroughly
Gently dry by patting or blotting with toilet tissue or soft cloth before applying
Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
Children under 12 years of age: Consult a doctor

Other Information

STORAGE AND HANDLING SECTION

Store at 25 deg. C (77F); excursions permitted to 15-30 deg. C (59-86F)
[see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cetyl alcohol, stearic acid, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil,

lecithin, hexylene glycol, sodium polyacrylate, caprylyl glycol, ethoxydiglycol, potassium sorbate, phenoxyethanol

Lidocaine 5%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68752-015-45	GM - Gram	68752-015	b819ec23-1c5f-4935-ae70-7d7e69a2907a	1	2017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	1
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Lidocaine 5%
WATER
CETYL ALCOHOL
STEARIC ACID
ALOE VERA LEAF
JOJOBA OIL
HEXYLENE GLYCOL
CAPRYLYL GLYCOL
DIETHYLENE GLYCOL MONOETHYL ETHER
POTASSIUM SORBATE
PHENOXYETHANOL
LECITHIN, SOYBEAN
SODIUM POLYACRYLATE (8000 MW)
LIDOCAINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68752-015	68752-015-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
CETYL ALCOHOL	936JST6JCN	IACT
STEARIC ACID	4ELV7Z65AP	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
JOJOBA OIL	724GKU717M	IACT
HEXYLENE GLYCOL	KEH0A3F75J	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
SODIUM POLYACRYLATE (8000 MW)	285CYO341L	IACT
LIDOCAINE	98PI200987	ACTIB

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 2 · 88 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
DIETHYLENE GLYCOL MONOETHYL ETHER	DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	GEL / TRANSDERMAL		87 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 equally ranked IID candidates
HEXYLENE GLYCOL	HEXYLENE GLYCOL	KEH0A3F75J	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
HEXYLENE GLYCOL	HEXYLENE GLYCOL	KEH0A3F75J	GEL / TOPICAL		280 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION/ DROPS / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.1 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	TABLET, FILM COATED / ORAL	0.33 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	POWDER, FOR SUSPENSION / ORAL		39 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHER	DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	SYSTEM / TOPICAL		1720 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
HEXYLENE GLYCOL	HEXYLENE GLYCOL	KEH0A3F75J	OINTMENT / TOPICAL	12 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii candidate 19 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	EMULSION / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHER	DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	PASTE / ORAL		48 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	TABLET, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	CAPSULE / ORAL	20 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	AEROSOL, FOAM / TOPICAL		8 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHER	DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	GEL / TOPICAL		2500 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 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
074efd3b-bebf-8dad-e063-6294a90af4f3			6aac0204-dd23-4356-8d8a-9f4c3bdc543d	2023-10-09	Warnings	Exact identifier spl set id: 6aac0204-dd23-4356-8d8a-9f4c3bdc543d

Reported adverse events (FAERS/openFDA)#

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

Lidocaine 5%

Label at a glance#

Dosage and administration

Storage and handling

Label contents#

Full prescribing information#

Active Ingredient

Purpose

Use

WARNINGS:

When using this product

Stop use and ask doctor if:

Keep out of the reach of children

Directions

Other Information

Inactive ingredients

Lidocaine 5%

Related RxNorm Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#