5820382 Meijer 4x Med Gel

Manufacturer
Meijer Distribution Inc | Lornamead Inc.
Effective date
2021-07-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:40:27

Label at a glance#

ProductMeijer Severe 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, 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.

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

TAMPER EVIDENT: Do not use if tube tip is cut prior to use.

DIST. BY MEIJER DISTRIBUTION, INC.; GRAND RAPIDS, MI 49544

www.meijer.com • 1-877-777-2743

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

meijer®

TRIPLE MEDICATED

toothache relief gel

Benzocaine 20% I Menthol 0.5% l Zinc Chloride 0.15%

Oral Pain Reliever and Astringent

  • Maximum strength 20% Benzocaine to relieve oral pain
  • Astringint to relieve gum irritation
  • Soothing Menthol

NET WT 0.25 OZ (7g)

Meijer_Severe_TripleMedGel_2821367R3Meijer_Severe_TripleMedGel_2821367R3

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
41250-55241250-552-79

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
c73ef95d-92aa-e0ab-e053-2995a90aa76b849f7d01-a395-2b3a-e053-2991aa0af60b2021-07-16WarningsExact identifier
spl id: c73ef95d-92aa-e0ab-e053-2995a90aa76b
spl set id: 849f7d01-a395-2b3a-e053-2991aa0af60b

Reported adverse events (FAERS/openFDA)#

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