5820622 Walgreens NBE Anbesol Gel

Manufacturer
Walgreens | Lornamead Products
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:17:38

Label at a glance#

ProductNBE Anbesol
Active ingredientBENZOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

OTC - PURPOSE SECTION

Oral anesthetic

INDICATIONS & USAGE SECTION

temporarily relieves pain associated with mouth and gum irritations

WARNINGS SECTION

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: * pale, gray, or blue colored skin (cyanosis) * headache * rapid heart rate * shortness of breath * dizziness or lightheadedness * fatigue or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age

Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

to open tube, cut tip of tube on score mark * adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist/doctor * children under 12 years of age: adult supervision should be given in the use of this product * children under 2 years of age: do not use * for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting

OTHER SAFETY INFORMATION

store at 20-25C (68-77F). Do not refrigerate.

INACTIVE INGREDIENT SECTION

blue 1, carbomer, flavor, glycerin, polyethylene glycol, propylene glycol, red 40, sodium saccharin, sorbic acid, water, yellow 10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton R1Carton R1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0316-69NBE Anbesol1 in 1 CARTONGEL16
0363-0316-69NBE Anbesol9 g in 1 TUBEGEL96

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
0363-03160363-0316-69

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
NBE AnbesolBENZOCAINEWalgreensdd2a3125-32f8-5fff-e053-2995a90ac7202025-11-21WarningsExact identifier
ndc (package): 0363-0316-69
ndc (product): 0363-0316
ndc11 (package): 00363031669
spl id: 441e7c47-f347-a262-e063-6394a90ae697
spl set id: dd2a3125-32f8-5fff-e053-2995a90ac720

Reported adverse events (FAERS/openFDA)#

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