FDA.reportPublic FDA data

Lidocaine Numbing Cream

Manufacturer
ONE2ZEE LIMITED LIABILITY COMPANY | YASH PHARMACEUTICALS
Effective date
2020-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:07:45

Label at a glance#

ProductLidocaine Numbing Cream
Active ingredientLIDOCAINE
Label structure8 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

4 oz label4 oz 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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130373581000012GTIN-13: 0373581000012
EAN-13: 0373581000012
GTIN-12: 373581000012
UPC-A: 373581000012
GTIN storage (14 digits): 00373581000012		LIDO5_4oz_label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55629-050-012022-01-28C16284748780-1d6a99b39-3b33-a426-e053-dadaa90af4c2Lidocaine Numbing Cream topical anesthetic cream with vitamin E

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-050-01Lidocaine Numbing Cream113 mL in 1 JARCREAM1131

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 rows20200424_f54bcf70-0da8-49fe-8e25-0637ccacf038.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
55629-05055629-050-01

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 · Source PDF

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
3fdef3ae-192f-466e-a03b-468493562073f54bcf70-0da8-49fe-8e25-0637ccacf0382020-04-24WarningsExact identifier
spl id: 3fdef3ae-192f-466e-a03b-468493562073
spl set id: f54bcf70-0da8-49fe-8e25-0637ccacf038

Reported adverse events (FAERS/openFDA)#

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