4x Medicated Toothache and Gum Cream

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#

Product4x Medicated Toothache and Gum Cream
Active ingredientBENZALKONIUM CHLORIDE, BENZOCAINE, ZINC CHLORIDE, MENTHOL, UNSPECIFIED FORM
Label structure7 sections

Dosage and administration

cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of 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 under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13% . . . Oral antiseptic

Benzocaine 20% . . . Oral pain reliever

Menthol 0.5% . . . Oral pain reliever

Zinc chloride 0.15% . . . Oral astringent

OTC - PURPOSE SECTION

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

WARNINGS SECTION

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

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 - DO NOT 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.

Directions

DOSAGE & ADMINISTRATION SECTION

cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of 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 under 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

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 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

ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

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
62721-560162721-5601-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a757d19a-e4ea-69d6-e053-2a95a90a72caa757d19a-e4e9-69d6-e053-2a95a90a72ca2020-06-05WarningsExact identifier
spl id: a757d19a-e4ea-69d6-e053-2a95a90a72ca
spl set id: a757d19a-e4e9-69d6-e053-2a95a90a72ca