FDA.reportPublic FDA data

Lidocaine Numbing Cream

Manufacturer
ONE2ZEE LIMITED LIABILITY COMPANY | YASH PHARMACEUTICALS
Effective date
2022-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:50

Label at a glance#

ProductLidocaine Numbing Cream
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For the temporary relief of pain and discomfort associated with anorectal disorders.

Dosage and administration

Children under 12 : Consult a doctor. Adults and children 12 years and older : For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product. Apply externally up to 6 times per day.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 5.0%

Purpose

OTC - PURPOSE SECTION

  • External Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of pain and discomfort associated with anorectal disorders.

Warnings:

WARNINGS SECTION

  • For external use only. If condition worsens or does not improve within 7 days, consult a doctor.

When using this product,

OTC - WHEN USING SECTION

  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • In case of bleeding, consult a doctor promptly.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact the Poison Control Center immediately.
  • If pregnant or breast feeding, ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

Children under 12: Consult a doctor.

Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product. Apply externally up to 6 times per day.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate

Other Information:

SPL UNCLASSIFIED SECTION

Store at room temperature. Avoid direct sunlight. Do not use if tamper evident packaging has been breached or is missing. See bottom of this jar for lot number and expiry date.

Distributed by: Wellspring Airmont, NY 10952 U.S.A.

Packaging label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIDO5_55oz_labelLIDO5_55oz_label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1534792lidocaine 5 % Topical CreamPSN1
1534792lidocaine 50 MG/ML Topical CreamSCD1
1534792lidocaine 5 % Topical CreamSY1

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55629-050-552024-01-30C16284748780-11030e365-3c3b-111a-e063-dadaa90a10e2Lidocaine Numbing Cream topical anesthetic cream with vitamin E

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-050-55Lidocaine Numbing Cream156 mL in 1 JARCREAM1561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-050LIDOCAINE NUMBING CREAM (LIDOCAINE) CREAM [ONE2ZEE LIMITED LIABILITY COMPANY]1Legacy NDC, 1 package rows20220616_8707a853-953a-47af-bade-850776164f83.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
55629-05055629-050-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER 9404Q93RCW27EIACT
CHOLESTEROL97C5T2UQ7JIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
c27cccf1-ce98-4458-9004-801b1b46da808707a853-953a-47af-bade-850776164f832022-06-14WarningsExact identifier
spl id: c27cccf1-ce98-4458-9004-801b1b46da80
spl set id: 8707a853-953a-47af-bade-850776164f83

Reported adverse events (FAERS/openFDA)#

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