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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-5337
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 10, 2025
FDA Product Classification

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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Walgreens - FDA Drug Approval Details