MedPath

Walgreens

5820337 Walgreens Max Str Oral Anesthetic Paste

Approved
Approval ID

2ef0eb2c-b614-44e2-b9b3-97b02c654977

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 10, 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

NDC Product Code0363-5337
Application NumberM022
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateJune 10, 2025
Generic NameBenzocaine

INGREDIENTS (9)

MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022Y
Classification: IACT
PECTINInactive
Code: 89NA02M4RX
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
BENZOCAINEActive
Quantity: 20 g in 100 g
Code: U3RSY48JW5
Classification: ACTIB
SACCHARINInactive
Code: FST467XS7D
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/30/2013

Carton R2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/6/2013

Usefor the temporary relief of pain due to:

  • canker sores
  • cold sores
  • fever blisters
  • minor irritation of the mouth and gums
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/30/2013

Questions or comments? 1-877-777-2743

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

MADE IN U.S.A.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/30/2013

Active ingredient

Benzocaine 20%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/6/2019

Purpose

Oral pain reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 8/30/2013

Warnings

**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.

When using this product

  • avoid contact with eyes
  • do not use more than directed
  • do not use for more than 7 days unless told to do so by a dentist or doctor.

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/30/2013

Directions

  • cut open tip of tube on score mark ***adults and children 2 years of age and older:**apply to the 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:**ask a dentist or doctor
  • 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

LOINC: 60561-8Updated: 8/30/2013

Other informationDo not use if tip is cut prior to opening. This preparation is intended for use in cases of toothache, only as a

temporary expedient until a dentist can be consulted. Do not use continuously.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/30/2013

Inactive ingredientsCellulose Gum, Gelatin, Menthol, Methyl Salicylate, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin.

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