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3x medicated mouth sore gel - Medication Information

Product NDC Code 69842-660
Drug Name

3x medicated mouth sore gel

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
Benzocaine 20 g/100g
Menthol, unspecified form .1 g/100g
Zinc chloride .15 g/100g
Route ORAL
Dosage Form GEL
RxCUI drug identifier 2266762
Application Number part356
Labeler Name CVS
Packages
Package NDC Code Description
69842-660-09 1 tube in 1 carton (69842-660-09) / 11.9 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Benzocaine 20% . . . Oral pain reliever Menthol 0.1% . . . 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 * 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 shoul dbe 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.
allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

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

Purpose

Information about the drug product’s indications for use.
Uses temporarily relives pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums

Spl product data elements

Usually a list of ingredients in a drug product.
3x Medicated Mouth Sore Gel Benzocaine BENZOCAINE BENZOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ZINC CHLORIDE ZINC CATION POLYETHYLENE GLYCOL 400 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) PROPYLENE GLYCOL POVIDONE K90 SORBIC ACID STEARYL ALCOHOL ALLANTOIN WATER EDETATE DISODIUM EDETIC ACID POLYSORBATE 60 SACCHARIN SODIUM SACCHARIN METHYL SALICYLATE Clear to yellow tint

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.

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