Numb520 Spray

Manufacturer
Clinical Resolution Laboratory, Inc.
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:05:41

Label at a glance#

ProductNumb520
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

Temporarily relieves pain, itching, or swelling associated with anorectal disorders.

Dosage and administration

Sensitivity test advised prior to use. Apply sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs (90 seconds). You may reapply to continue numbing effect. Apply up to 6 times a day. Children under 12 year 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

Temporarily relieves pain, itching, or swelling associated with anorectal disorders.

Warnings

WARNINGS SECTION

(For external use only)

Do not use this product if

OTC - DO NOT USE SECTION

  • Pregnant or breastfeeding, ask a health professional before use
  • Tamper-evident shrink band around the container is broken.

When using this product

OTC - WHEN USING SECTION

  • Do not exceed the recommended daily 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.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately. 

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

  • Sensitivity test advised prior to use. Apply sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs (90 seconds). You may reapply to continue numbing effect.
  • Apply up to 6 times a day.
  • Children under 12 year 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, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylene Glycol, Benzyl Alcohol, Epinephrine HCL, Citric Acid, Disodium EDTA, Cholesterol, Sodium Metabisulfite, Lecithin, Polysorbate 80, Phenoxyethanol

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2045339lidocaine 5 % Topical SprayPSN5
2045339lidocaine 50 MG/ML Topical SpraySCD5
2045339lidocaine 5 % Topical SpraySY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63742-006-00Numb520123 mL in 1 BOTTLELIQUID1235
63742-006-01Numb520251 mL in 1 BOTTLELIQUID2515

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63742-006NUMB520 (LIDOCAINE) LIQUID [CLINICAL RESOLUTION LABORATORY, INC.]5Legacy NDC, 2 package rows20231227_26d74a03-98c6-4e99-a657-bfdd1b3dbf38.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63742-00663742-006-00, 63742-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d762cea-b5e3-6ff1-e063-6394a90aee0326d74a03-98c6-4e99-a657-bfdd1b3dbf382023-12-26WarningsExact identifier
spl id: 0d762cea-b5e3-6ff1-e063-6394a90aee03
spl set id: 26d74a03-98c6-4e99-a657-bfdd1b3dbf38

Reported adverse events (FAERS/openFDA)#

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