MedPath

3x Medicated Mouth Sore Gel

5820605 Walg 3x Gel

Approved
Approval ID

ad509f2a-05de-6c77-e053-2995a90ae526

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Walgreens

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benzocaine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-1605
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (15)

STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ZINC CHLORIDEActive
Quantity: 0.15 g in 100 g
Code: 86Q357L16B
Classification: ACTIM
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022Y
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MENTHOL, UNSPECIFIED FORMActive
Quantity: 0.1 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
BENZOCAINEActive
Quantity: 20 g in 100 g
Code: U3RSY48JW5
Classification: ACTIB
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/21/2021

Carton R2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/21/2021

temporarily relieves pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/21/2021

Benzocaine 20%

Menthol 0.1%

Zinc chloride 0.15%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/21/2021

Oral pain reliever

Oral pain reliever

Oral astringent

WARNINGS SECTION

LOINC: 34071-1Updated: 10/21/2021

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

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

LOINC: 34068-7Updated: 10/21/2021

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

LOINC: 51727-6Updated: 10/21/2021

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl acohol, water

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3x Medicated Mouth Sore Gel - FDA Drug Approval Details