FDA.reportPublic FDA data

Walgreens Anorectal Lidocaine Cream

Manufacturer
Walgreens Company
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:17

Label at a glance#

ProductWalgreens Anorectal Lidocaine Cream
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Dosage and administration

When practical, clean 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 externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor. To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% W/W

Purpose 

OTC - PURPOSE SECTION

Local Anesthetic 

Uses

INDICATIONS & USAGE SECTION

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Warnings

WARNINGS SECTION

For external use only.

When using this product

  • 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

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions 

DOSAGE & ADMINISTRATION SECTION

  • When practical, clean 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 externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other Information 

OTHER SAFETY INFORMATION

Store at controlled room temperature 68-77° F (20-25 °C)

Inactive ingredient

INACTIVE INGREDIENT SECTION

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

Principal Primary panel -Tube 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens             NDC 0363-5722-28

Anorectal

Lidocaine Cream 5%

NET WT 1 OZ (28.3g)

280250_WAG_LAX_000000_LidocaineCream_TUBE.jpg280250_WAG_LAX_000000_LidocaineCream_TUBE.jpg

Principal Primary Panel - Carton 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens NDC 0363-5722-28

Anorectal

Lidocaine Cream 5%

NET WT 1 OZ (28.3g)

551740_WAG_LAX_000000_LidocaineCream_BOX.jpg551740_WAG_LAX_000000_LidocaineCream_BOX.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN3
1366789lidocaine 50 MG/ML Rectal CreamSCD3
1366789lidocaine 5 % Rectal CreamSY3

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5722-28Walgreens Anorectal Lidocaine Cream28.3 g in 1 TUBECREAM28.33
0363-5722-28Walgreens Anorectal Lidocaine Cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5722WALGREENS ANORECTAL LIDOCAINE CREAM (5% LIDOCAINE) CREAM [WALGREENS COMPANY]3Current NDC, Legacy NDC, 2 package rows20241122_3052fac7-fd68-43f4-9950-8c07288a6b6d.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-57220363-5722-28

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
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
TROLAMINE9O3K93S3TKIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POLYSORBATE 806OZP39ZG8HIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHOLESTEROL97C5T2UQ7JIACT
WATER059QF0KO0RIACT

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
Walgreens Anorectal Lidocaine Cream5% LIDOCAINEWalgreens Company3052fac7-fd68-43f4-9950-8c07288a6b6d2024-11-20WarningsExact identifier
ndc (package): 0363-5722-28
ndc (product): 0363-5722
ndc11 (package): 00363572228
spl id: b3d51b97-4ce6-485f-ba0d-4f2ed2dd1a99
spl set id: 3052fac7-fd68-43f4-9950-8c07288a6b6d

Reported adverse events (FAERS/openFDA)#

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