Zensa Numbing Gel

Manufacturer
Alera Skin Care Products Inc.
Effective date
2023-09-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:47

Label at a glance#

ProductZensa Numbing Gel
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, LIDOCAINE
Label structure11 sections

Indications and uses

For temporary relief of local discomfort associated with anorectal disorders. For temporary relief of pain, soreness and burning. Temporarily shrinks hemorrhoidal tissue.

Dosage and administration

Children under 12 years of age: Consult a doctor. Apply externally to the affected area up to 4 times daily.

Storage and handling

Other Information See enclosed consumer leaflet prior to use. Store at 59°-86°F. Protect from freezing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% and Phenylephrine hydrochloride 0.25%

PURPOSE

OTC - PURPOSE SECTION

Local Anaesthetic

Vasoconstrictor

Protective

USES

INDICATIONS & USAGE SECTION

For temporary relief of local discomfort associated with anorectal disorders. For temporary
relief of pain, soreness and burning. Temporarily shrinks hemorrhoidal tissue.

WARNINGS

WARNINGS SECTION

For external use only.

Before use ask a doctor:
•if you are presently taking a prescription drug for high blood pressure or depression.

When using this product:

•certain persons can develop allergic reactions to ingredients in this product.
•if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Do not use this product if you have
heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland
unless directed by a doctor.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

•condition worsens or does not improve within 7 days

•bleeding occurs.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Children under 12 years of age: Consult a doctor.

Apply externally to the affected area up to 4 times daily.

STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

Other Information

See enclosed consumer leaflet prior to use. Store at 59°-86°F.
Protect from freezing.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbomer, Caprylyl Glycol, Propylene Glycol, Phenoxyethanol, Purified Water.

QUESTIONS

OTC - QUESTIONS SECTION

Questions? 1-844-441-7546

Zensa Numbing Gel 1 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zensa Numbing Gel 1 Oz CartonZensa Numbing Gel 1 Oz CartonZensa Numbing Gel 1 oz TubeZensa Numbing Gel 1 oz Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2621576lidocaine 5 % / phenylephrine HCl 0.25 % Rectal GelPSN1
2621576lidocaine 0.05 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal GelSCD1
2621576lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal GelSY1

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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f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69805-400-01Zensa Numbing Gel30 g in 1 TUBEGEL301
69805-400-01Zensa Numbing Gel1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69805-400ZENSA NUMBING GEL (LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%) GEL [ALERA SKIN CARE PRODUCTS INC.]1Current NDC, 2 package rows20231016_065a6eec-3896-0da8-e063-6394a90a849d.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
69805-40069805-400-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Zensa Numbing GelLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Alera Skin Care Products Inc.065a6eec-3896-0da8-e063-6394a90a849d2023-09-27WarningsExact identifier
ndc (package): 69805-400-01
ndc (product): 69805-400
ndc11 (package): 69805040001
spl id: 065a6eec-3897-0da8-e063-6394a90a849d
spl set id: 065a6eec-3896-0da8-e063-6394a90a849d

Reported adverse events (FAERS/openFDA)#

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