3x Medicated Mouth Sore Gel

Manufacturer
Lornamead
Effective date
2020-06-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:25:11

Label at a glance#

Product3x Medicated Mouth Sore Gel
Active ingredientMENTHOL, UNSPECIFIED FORM, BENZOCAINE, ZINC CHLORIDE
Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20% . . . Oral pain reliever

Menthol 0.1% . . . Oral pain reliever

Zinc chloride 0.15% . . . Oral astringent

OTC - PURPOSE SECTION

INDICATIONS & USAGE SECTION

temporarily relieves pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums

WARNINGS SECTION

Methemoglobinemia warning: use of this product may cause methemoglobinemia a serious condition that must be treated properly 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 develop: * 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 lovcal anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use * more than directed * for more than 7 days unless told to do so 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 reation 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 * do not use if tip is cut prior to opening * adults and children 2 years of age and older: apply to 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: do not use

INACTIVE INGREDIENT SECTION

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NBE Carton ArtworkNBE Carton Artwork

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62721-560062721-5600-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
a757a9f8-a33b-a731-e053-2995a90a5c4aa757a9f8-a33a-a731-e053-2995a90a5c4a2020-06-05WarningsExact identifier
spl id: a757a9f8-a33b-a731-e053-2995a90a5c4a
spl set id: a757a9f8-a33a-a731-e053-2995a90a5c4a

Reported adverse events (FAERS/openFDA)#

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