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4x medicated toothache and gum cream - Medication Information

Product NDC Code 37808-116
Drug Name

4x medicated toothache and gum cream

Type Brand
Pharm Class Allergens [CS],
Cell-mediated Immunity [PE],
Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE],
Increased Histamine Release [PE],
Standardized Chemical Allergen [EPC]
Active Ingredients
Benzalkonium chloride .13 g/100g
Benzocaine 20 g/100g
Menthol, unspecified form .25 g/100g
Zinc chloride .15 g/100g
Route ORAL
Dosage Form CREAM
RxCUI drug identifier 2370903
Application Number part356
Labeler Name HEB
Packages
Package NDC Code Description
37808-116-69 1 tube in 1 carton (37808-116-69) / 9.4 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Purpose Benzalkonium chloride 0.13% . . . Oral antiseptic Benzocaine 20% . . . . . . . . . . . . . Oral pain reliever Menthol 0.26% . . . . . . . . . . . . . . .Oral pain reliever Zinc chloride 0.15% . . . . . . . . . . .Oral astringent

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions * cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amoutn 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

Purpose

Information about the drug product’s indications for use.
Use for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

Spl product data elements

Usually a list of ingredients in a drug product.
4x Medicated Toothache and Gum Cream Benzocaine POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 BENZOCAINE BENZOCAINE SACCHARIN SODIUM SACCHARIN SORBIC ACID TITANIUM DIOXIDE AMMONIUM GLYCYRRHIZATE GLYCYRRHIZIN BENZALKONIUM CHLORIDE BENZALKONIUM ZINC CHLORIDE ZINC CATION MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM Cloudy

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Carton Artwork

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
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

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API