Numb25

Manufacturer: Clinical Resolution Laboratory, Inc.
Effective date: 2025-05-15
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:01:11

Label at a glance#

ProductNumb25

Active ingredientLIDOCAINE

Label structure8 sections

Indications and uses

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

Dosage and administration

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse 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 disorders or inflammation.

Warnings

WARNINGS SECTION

(For external use only)

Do not use

OTC - DO NOT USE SECTION

this product if

pregnant or breastfeeding, ask a health professional before use.
in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
seal is broken or missing.

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 finger 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 rinse 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 at room temperature 15°-30°C (59°-86°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Water, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine

Package Labeling:63742-035-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label6

Package Labeling:63742-035-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label7

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1366789	lidocaine 5 % Rectal Cream	PSN	4
1366789	lidocaine 50 MG/ML Rectal Cream	SCD	4
1366789	lidocaine 5 % Rectal 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
63742-035-01	Numb25	38 g in 1 BOTTLE	CREAM	38		4
63742-035-02	Numb25	125 g in 1 BOTTLE	CREAM	125		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63742-035	NUMB25 (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]	4	Current NDC, 2 package rows	20250519_cfcb839d-47b4-4925-bb30-97b64d20d2b3.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Numb25
LIDOCAINE
ALLANTOIN
ALOE VERA LEAF
BENZYL ALCOHOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
CHOLESTEROL
DIMETHYL ISOSORBIDE
EDETATE DISODIUM ANHYDROUS
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
PROPYLENE GLYCOL
WATER
.ALPHA.-TOCOPHEROL ACETATE
TRIDECETH-6
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63742-035	63742-035-01, 63742-035-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALLANTOIN	344S277G0Z	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
CHOLESTEROL	97C5T2UQ7J	IACT
DIMETHYL ISOSORBIDE	SA6A6V432S	IACT
EDETATE DISODIUM ANHYDROUS	8NLQ36F6MM	IACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE	VLW429K27K	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TRIDECETH-6	3T5PCR2H0C	IACT
TROLAMINE	9O3K93S3TK	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
Numb25	LIDOCAINE	Clinical Resolution Laboratory, Inc.	cfcb839d-47b4-4925-bb30-97b64d20d2b3	2025-05-15	Warnings	Exact identifier ndc (package): 63742-035-02 ndc (package): 63742-035-01 ndc (product): 63742-035 ndc11 (package): 63742003501 ndc11 (package): 63742003502 spl id: 353212d3-6309-14b4-e063-6394a90a5b29 spl set id: cfcb839d-47b4-4925-bb30-97b64d20d2b3

Reported adverse events (FAERS/openFDA)#

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