Walgreens Anorectal Lidocaine Cream Lidocaine 5%

Manufacturer
WALGREENS CO.
Effective date
2020-10-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:43

Label at a glance#

ProductLidocaine 5%
Active ingredientLIDOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 5%

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, triethanolamine, vitamin E, purified water.

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: consult a doctor

To use finger cots: Roll one finger cot over finger. Gently squeeze cream over affected area.

INDICATIONS & USAGE SECTION

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

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

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.

OTC - PURPOSE SECTION

Local anesthetic

OTHER SAFETY INFORMATION

Store at room temperature (20-25 C) (68-77 F). Avoid excessive heat and cold. Protect from sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

453453

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
0363-4530-192025-01-30C16284748780-12cef2736-70b4-d83d-e063-dadaa90ab31fWalgreens Anorectal Lidocaine Cream Lidocaine 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4530-19Lidocaine 5%28.3 g in 1 PACKAGEOINTMENT28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4530LIDOCAINE 5% OINTMENT [WALGREENS CO.]2Legacy NDC, 1 package rows20201016_995fffc0-3203-0810-e053-2995a90ae276.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4530-19GM - Gram0363-45300ae1bda7-5c07-47a6-9cbf-a2ab367097f012022-06-06

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
0363-45300363-4530-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
b1baafb1-ad97-14f8-e053-2995a90a6341995fffc0-3203-0810-e053-2995a90ae2762020-10-15WarningsExact identifier
spl id: b1baafb1-ad97-14f8-e053-2995a90a6341
spl set id: 995fffc0-3203-0810-e053-2995a90ae276

Reported adverse events (FAERS/openFDA)#

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