Walgreens Instant Toothache & Gum Relief Gel Triple Med

Manufacturer
Walgreens | Lornamead Inc.
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:40:49

Label at a glance#

ProductWalgreens Instant Toothache and Gum Relief Triple Medicated
Active ingredientZINC CHLORIDE, MENTHOL, BENZOCAINE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Benzocaine 20%

Menthol 0.5%

Zinc Chloride 0.15%

OTC - PURPOSE SECTION

Purpose

Oral pain reliever

Oral pain reliever

Astringent

INDICATIONS & USAGE SECTION

Use

  • for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums

WARNINGS SECTION

Warnings

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

OTC - DO NOT USE SECTION

Do not use

  • more than directed
  • for more than 7 days unless directed by a dentist or doctor
  • for teething
  • in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • swelling, reash 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • cut open tip of tube on score mark
  • adults and children 2 years of age and older: apply a small amount of the product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.
  • children between 2 and 12 years of age should be supervised in the use of this product
  • children under 2 years of age: do not use

OTHER SAFETY INFORMATION

Other information

  • do 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
  • this formula will stay in place for extended duration of relief
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

INACTIVE INGREDIENT SECTION

Inactive ingredientsblue 1, cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin

SPL UNCLASSIFIED SECTION

Questions or comments? 1-800-925-4733

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Instant Toothache & Gum Relief

ORAL PAIN RELIEVER / ASTRINGENT

SEVERE GEL TRIPLE MEDICATED

  • 20% maximum strength benzocaine for to relieve oral pain
  • Astringent to relieve gum irritation
  • Menthol to soothe

NET WT 0.25 OZ (7.0 g)

Walgreens Toothache Gum Relief Gel 2821380R1Walgreens Toothache Gum Relief Gel 2821380R1

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5351WALGREENS INSTANT TOOTHACHE AND GUM RELIEF TRIPLE MEDICATED (BENZOCAINE, MENTHOL, ZINC CHLORIDE) GEL [WALGREENS]5Legacy NDC20230112_8372df2f-6399-0667-e053-2991aa0a3e7f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-53510363-5351-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

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
441e93b2-7032-fe2d-e063-6294a90ab7778372df2f-6399-0667-e053-2991aa0a3e7f2025-11-21WarningsExact identifier
spl set id: 8372df2f-6399-0667-e053-2991aa0a3e7f

Reported adverse events (FAERS/openFDA)#

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