5820635 Walgreens Mouth Sore Relief Liquid (Kanka, 8015303-44C-247-3)

Manufacturer
Walgreens | Lornamead, Inc | HK Kolmar Canada, Inc
Effective date
2025-11-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-31 01:02:58

Label at a glance#

ProductWalgreens Mouth Sore Relief
Active ingredientBENZOCAINE
Label structure7 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 2 years of age and over: wipe liquid on with cotton, or cotton swab, or fingertip, apply to the affected area up to 4 times daily or as directed by a doctor/dentist
  • children under 12 years of age: adult supervision should be given in the use of this product
  • children under 2 yeasr 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

WARNINGS SECTION

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated properly because it reduces the amount of oxygen carried in blood. This can occur even uf you have used this product before. Stop use and seek immediate medical attention if you or a child in you 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 - for teething - in children under 2 years of age

When using this product - avoid contact with eyes - do not exceed recommended dosage - do not use more than directed for more than 7 days unless directed by a doctor/dentist

Stop use and ask a doctor or dentist if - sore mouth symptoms do not improve in 7 days - irritation, pain or redness persists or worsens - swelling, rash or fever develops

Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Inactive ingredients benzyl alcohol, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavor, methylparaben, polyethylene glycol, propylene glycol, sodium saccharin, water

INDICATIONS & USAGE SECTION

Uses - temporarily relieves pain associated with the following mouth and gum irriations:

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
  • dentures

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Purpose - Oral Anesthetic/Analgesic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CardCard R5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-53340363-5334-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-08-12full-release2026-06-01 01:10:02

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
3c30f23d-25d3-0a60-e063-6394a90a5328253d7ea2-e48e-c7d7-e063-6394a90ae0012025-08-12WarningsExact identifier
spl set id: 253d7ea2-e48e-c7d7-e063-6394a90ae001

Reported adverse events (FAERS/openFDA)#

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