SECONDARY NUMB Lidocaine Phenylephrine Gel

Manufacturer
LALANI Rx Consulting, Inc.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:52

Label at a glance#

ProductSECONDARY NUMB Lidocaine Phenylephrine Gel
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

• Temporary relief of pain • Temporarily shrinks hemorrhoidal tissue • For the temporary relief of anorectal discomfort associated with hemorrhoids

Dosage and administration

Adults and children 12 years and over: • Children under 12 consult a doctor • Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product • Apply to the affected area up to 3 times daily • Do not use more often than directed

Label contents#

Full prescribing information#

Active ingredients (w/w)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% Phenylephrine HCL 0.25%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Vaso Constrictor

Uses

INDICATIONS & USAGE SECTION

• Temporary relief of pain • Temporarily shrinks hemorrhoidal tissue • For the temporary relief of anorectal discomfort associated with hemorrhoids

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficuly in urination

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

• presently taking medicine for high blood pressure or depression

When using this product

OTC - WHEN USING SECTION

• do not put it into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

• bleeding occurs • condition worsens or does not improve within 7 days • redness, irritation, swelling, pain or other symptoms occur. If allergic  reaction to product occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call poison control centre or get medical help right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over: • Children under 12 consult a doctor • Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product • Apply to the affected area up to 3 times daily • Do not use more often than directed



Inactive ingredients

INACTIVE INGREDIENT SECTION

Aminomethylpropanol, Aqua, Benzyl Alcohol, Caprylyl Glycol, Carbomer, Phenoxyethanol, Propylene Glycol

Questions?

OTC - QUESTIONS SECTION

1-844-782-2387

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2621576lidocaine 5 % / phenylephrine HCl 0.25 % Rectal GelPSN2
2621576lidocaine 0.05 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal GelSCD2
2621576lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal GelSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
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b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
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49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83120-378-00SECONDARY NUMB Lidocaine Phenylephrine Gel31.18 g in 1 TUBEGEL31.182
83120-378-00SECONDARY NUMB Lidocaine Phenylephrine Gel1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83120-378SECONDARY NUMB LIDOCAINE PHENYLEPHRINE GEL (LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE) GEL [LALANI RX CONSULTING, INC.]2Current NDC, Legacy NDC, 2 package rows20231106_0f13f7b5-e3b1-451e-a6d6-e7e15bd04443.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83120-37883120-378-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
SECONDARY NUMB Lidocaine Phenylephrine GelLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDELALANI Rx Consulting, Inc.0f13f7b5-e3b1-451e-a6d6-e7e15bd044432023-11-06WarningsExact identifier
ndc (package): 83120-378-00
ndc (product): 83120-378
ndc11 (package): 83120037800
spl id: 0976eff9-48c6-1669-e063-6394a90a8240
spl set id: 0f13f7b5-e3b1-451e-a6d6-e7e15bd04443

Reported adverse events (FAERS/openFDA)#

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