3x Medicated Mouth Sore Gel
- Manufacturer
- Walgreens | Lornamead Products
- Effective date
- 2025-11-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 01:16:13
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Benzocaine 20%
Menthol 0.1%
Zinc chloride 0.15%
OTC - PURPOSE SECTION
Oral pain reliever
Oral pain reliever
Oral astringent
INDICATIONS & USAGE SECTION
temporarily relieves pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums
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 (1-800-222-1222).
DOSAGE & ADMINISTRATION SECTION
cut open tip of tube on score mark * do not use if tip is cut prior to opening * adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use
INACTIVE INGREDIENT SECTION
allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl acohol, water
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2266762 | benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral Gel | PSN | 8 |
| 2266762 | benzocaine 0.2 MG/MG / menthol 0.001 MG/MG / zinc chloride 0.0015 MG/MG Oral Gel | SCD | 8 |
| 2266762 | benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral Gel | SY | 8 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-1605-19 | 3x Medicated Mouth Sore Gel | 11.9 g in 1 TUBE | GEL | 11.9 | 8 | |
| 0363-1605-19 | 3x Medicated Mouth Sore Gel | 1 in 1 CARTON | GEL | 1 | 8 |
Products#
Every source-derived product name is available through these pages.
- 3x Medicated Mouth Sore Gel
- Benzocaine
- ALLANTOIN
- STEARYL ALCOHOL
- WATER
- EDETATE DISODIUM
- EDETIC ACID
- ZINC CHLORIDE
- ZINC CATION
- POLYSORBATE 60
- METHYL SALICYLATE
- PROPYLENE GLYCOL
- MENTHOL, UNSPECIFIED FORM
- CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
- POLYETHYLENE GLYCOL 400
- POVIDONE K90
- SORBIC ACID
- SACCHARIN SODIUM
- SACCHARIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-1605 | 0363-1605-19 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3x Medicated Mouth Sore Gel | BENZOCAINE | Walgreens | ad509f2a-05de-6c77-e053-2995a90ae526 | 2025-11-13 | Warnings | 0363-1605-19 0363-1605 00363160519 437fcace-4b78-b891-e063-6294a90ac3cb ad509f2a-05de-6c77-e053-2995a90ae526 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
