Anorectal Cream [GNP]

Manufacturer
Amerisource Bergen | Inspec Solutions LLC
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:16:15

Label at a glance#

ProductAnorectal
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.

Dosage and administration

Cleanse affected area and gently dry. Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement • Children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active ingredient                                 Purpose

OTC - ACTIVE INGREDIENT SECTION


Lidocaine 5%........................................Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.

Warnings For external use only.

WARNINGS SECTION


When using this product • do not get into eyes. • do not exceed the recommended daily 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 • condition worsens or does not improve within 7 days. • in case of bleeding, consult a doctor promptly • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse affected area and gently dry. Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement • Children under 12 years of age: consult a doctor.

Other Information

OTHER SAFETY INFORMATION

Store at 25° C (77°F); excursions permitted to 15-30° C (59-86° F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

 888-793-8450

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-652-032025-12-09C16284748780-11030e365-6f2a-111a-e063-dadaa90a10e2Anorectal Cream [GNP]
46122-652-032024-01-30C16284748780-11030e365-6f2a-111a-e063-dadaa90a10e2Anorectal Cream [GNP]

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-652ANORECTAL (LIDOCAINE) CREAM [AMERISOURCE BERGEN]3Legacy NDC20220118_e66da6eb-7ee8-416d-a20f-45e5c42d47d6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-652-03GM - Gram46122-65272225a0c-eee4-4fcf-8b76-e77f9cd410cb12021-09-07

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
46122-65246122-652-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
4585d89c-61a8-025e-e063-6394a90a75f3e66da6eb-7ee8-416d-a20f-45e5c42d47d62025-12-09WarningsExact identifier
spl set id: e66da6eb-7ee8-416d-a20f-45e5c42d47d6

Reported adverse events (FAERS/openFDA)#

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