4x Medicated Toothache and Gum Cream
5820612 4x Med Cream Kroger
a8c5090a-24f9-4e73-e053-2a95a90acca0
HUMAN OTC DRUG LABEL
Aug 12, 2025
Kroger
DUNS: 006999528
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 (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
OTC - ACTIVE INGREDIENT SECTION
Benzalkonium chloride 0.13% . . . Oral antiseptc
Benzocaine 20% . . . Oral pain reliever
Menthol 0.26% . . . Oral pain reliever
Zinc chloride 0.15% . . . Oral astringent
OTC - PURPOSE SECTION
Use * for the temporary relief of pain due to toothaches * to help prevent against infection of minor oral irritation
WARNINGS SECTION
Methemoglobinmia warning: use of this product may cause methemoglobinemia, a serious condition which 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" anethetics
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 2years of age
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 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
Other information * do not use if tip is cut prior to opening * this preparatation 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
ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide