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#
Contacts and useful links#
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)
Products#
Every source-derived product name is available through these pages.
- Meijer Severe Toothache and Gum Relief Triple Medicated
- Benzocaine, Menthol, Zinc chloride
- FD&C BLUE NO. 1
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- PETROLATUM
- MINERAL OIL
- PECTIN
- SACCHARIN SODIUM
- SACCHARIN
- METHYL SALICYLATE
- GELATIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- ZINC CHLORIDE
- ZINC CATION
- MENTHOL
- BENZOCAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41250-552 | 41250-552-79 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PECTIN | 89NA02M4RX | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| GELATIN | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| ZINC CHLORIDE | 86Q357L16B | ACTIM |
| MENTHOL | L7T10EIP3A | ACTIB |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| c73ef95d-92aa-e0ab-e053-2995a90aa76b | 849f7d01-a395-2b3a-e053-2991aa0af60b | 2021-07-16 | Warnings | c73ef95d-92aa-e0ab-e053-2995a90aa76b 849f7d01-a395-2b3a-e053-2991aa0af60b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
