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Manufacturer: Clinical Resolution Laboratory, Inc.
Effective date: 2023-12-26
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:05:46

Label at a glance#

ProductNumb 100

Active ingredientLIDOCAINE

Label structure7 sections

Indications and uses

For the temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.

Dosage and administration

Adults: When practical, cleanse the affected area with mild soap and warm water and rise thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply up to 6 times a day. Children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.

Warnings

WARNINGS SECTION

(For external use only)

Do not use

OTC - DO NOT USE SECTION

this product if

Pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.
In case of accidental overdose, contact a doctor or Poison Control Center immediately.
Tamper Evident "Warranty Void...Seal..."label atop the container is broken.

When using this product

OTC - WHEN USING SECTION

Do not exceed the recommended daily dosage unless directed by a doctor.
Certain persons can develop allergic reactions to ingredients in this product.
Do not put this product into the rectum by using fingers or any medical device or applicator.

Stop use and ask a doctor if

OTC - STOP USE SECTION

The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical attention immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults: When practical, cleanse the affected area with mild soap and warm water and rise thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product.
Apply up to 6 times a day.
Children under 12 years of age: consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

Keep away from direct sunlight or heat.
Store in room temperature (59-86°F / 15-30°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ethoxydiglycol, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Sodium Polacrylate, Hydrogenated Polycene, Trideceth-10, Cholesterol, Allantoin, Tocopheryl Acetate, Polysorbate-80

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1534792	lidocaine 5 % Topical Cream	PSN	4
1534792	lidocaine 50 MG/ML Topical Cream	SCD	4
1534792	lidocaine 5 % Topical Cream	SY	4

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63742-003-01	Numb 100	38 g in 1 BOTTLE	CREAM	38		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63742-003	NUMB 100 (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]	4	Legacy NDC, 1 package rows	20231227_e75eb3e0-853b-4b85-8c31-86cbf58effaa.zip

Products#

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

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

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LIDOCAINE
WATER
TROLAMINE
CARBOXYPOLYMETHYLENE
PROPYLENE GLYCOL
BENZYL ALCOHOL
DIETHYLENE GLYCOL MONOETHYL ETHER
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
TRIDECETH-10
CHOLESTEROL
ALLANTOIN
.ALPHA.-TOCOPHEROL ACETATE
POLYSORBATE 80

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63742-003	63742-003-01

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
TROLAMINE	9O3K93S3TK	IACT
CARBOXYPOLYMETHYLENE	0A5MM307FC	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE	VLW429K27K	IACT
TRIDECETH-10	G624N6MSBA	IACT
CHOLESTEROL	97C5T2UQ7J	IACT
ALLANTOIN	344S277G0Z	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
LIDOCAINE	98PI200987	ACTIB

Source Document#

Source XML

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
0d762cea-b5e2-6ff1-e063-6394a90aee03			e75eb3e0-853b-4b85-8c31-86cbf58effaa	2023-12-26	Warnings	Exact identifier spl id: 0d762cea-b5e2-6ff1-e063-6394a90aee03 spl set id: e75eb3e0-853b-4b85-8c31-86cbf58effaa

Reported adverse events (FAERS/openFDA)#

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