Numb Gel Anesthetic

Manufacturer
RENU LABORATORIES, INC.
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:07

Label at a glance#

ProductNumb Gel Anesthetic
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Topical anesthetic

INDICATIONS & USAGE SECTION

Uses: For temporary relief of pain associated with minor skin procedures

WARNINGS SECTION

For External Use only.

OTC - WHEN USING SECTION

When using this product, do not use in or near the eyes • do not use in large quantities, particularly over raw surfaces or blistered areas. • do not use on puncture wounds • for more than one week without consulting a doctor

OTC - STOP USE SECTION

Stop Use and ask a doctor if:

  • allergic reaction 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: adults and children 2 years and older: apply to the affected area up to 3 to 4 times a day

children under 2 years - ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin

OTHER SAFETY INFORMATION

Store at 20 - 25 C (68 - 77 degrees F)

OTC - QUESTIONS SECTION

Questions? 574-975-3632

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JAR LABEL AND BOX ART

Numb box artNumb box art

Numb jar labelNumb jar label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN3
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD3
1010077lidocaine hydrochloride 4 % Topical GelSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-595-022024-01-30C16284748780-11030e365-4573-111a-e063-dadaa90a10e2NUMB Gel Anesthetic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-595-01Numb Gel Anesthetic28 g in 1 JARGEL283
76348-595-02Numb Gel Anesthetic1 in 1 BOXGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-595NUMB GEL ANESTHETIC (LIDOCAINE HCL) GEL [RENU LABORATORIES, INC.]3Legacy NDC, 2 package rows20220118_b4901def-ccf5-db77-e053-2a95a90a1bed.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-59576348-595-01, 76348-595-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
d5c9eac5-69d2-62be-e053-2a95a90a26a7b4901def-ccf5-db77-e053-2a95a90a1bed2022-01-17WarningsExact identifier
spl id: d5c9eac5-69d2-62be-e053-2a95a90a26a7
spl set id: b4901def-ccf5-db77-e053-2a95a90a1bed

Reported adverse events (FAERS/openFDA)#

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