4x Medicated Toothache and Gum Gel
5820602 4x Med Gel
a7577d5f-69cf-3f32-e053-2995a90aaba5
HUMAN OTC DRUG LABEL
Aug 12, 2025
CVS
DUNS: 062312574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
OTC - PURPOSE SECTION
Use
for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation
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
WARNINGS SECTION
Methemoglobinema warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly becuase 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
Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not imporve in 7 days * allergic reaction occurs
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 * dults and children 2 years of age and older: apply a small amount of product to the cavity and around teh 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
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 least one hour after applying
INACTIVE INGREDIENT SECTION
ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid