FDA.reportPublic FDA data

Lidocaine

Manufacturer
Nanjing Chengong Pharmaceutical Co., Ltd.
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:35

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

For the temporary relief of pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Dosage and administration

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply eyternally to the attected area un to 6 times a day. Children under 12 years of age: consult a doctor.

Storage and handling

Store at USP controlled room temperature 20-25℃ (68-77°F).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Warnings

WARNINGS SECTION

For external only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

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

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: apply eyternally to the attected area un to 6 times a day.
  • Children under 12 years of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at USP controlled room temperature 20-25℃ (68-77°F).

Inactive ingredient

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer homopolymer type C 980NF, cholesterol, isopropyl myristate, polysorbate 80, propylene glycol, purified water, soybean lecithin, tocopherol.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2678387lidocaine 4 % Rectal CreamPSN2
2678387lidocaine 40 MG/ML Rectal CreamSCD2
2678387lidocaine 4 % Rectal CreamSY2

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-130383589301011GTIN-13: 0383589301011
EAN-13: 0383589301011
GTIN-12: 383589301011
UPC-A: 383589301011
GTIN storage (14 digits): 00383589301011		Labeling.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83589-301-01Lidocaine30 g in 1 TUBECREAM302
83589-301-01Lidocaine1 in 1 BOXCREAM12
83589-301-02Lidocaine1 in 1 BOXCREAM12
83589-301-02Lidocaine25 g in 1 TUBECREAM252
83589-301-03Lidocaine120 g in 1 TUBECREAM1202
83589-301-03Lidocaine1 in 1 BOXCREAM12

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83589-30183589-301-01, 83589-301-03, 83589-301-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CHOLESTEROL97C5T2UQ7JIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TOCOPHEROLR0ZB2556P8IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
SOYBEAN LECITHIN1DI56QDM62IACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT

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
5a1878af-394f-f99d-e063-6394a90a8e3cfbdea732-3f0b-c5a0-e053-6394a90a10a02026-08-28WarningsExact identifier
spl set id: fbdea732-3f0b-c5a0-e053-6394a90a10a0

Reported adverse events (FAERS/openFDA)#

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