The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
MADE WITH PRIDE AND CARE FOR H-E-B®SAN ANTONIO, TX 78204
Otc - Active Ingredient
Active ingredientsBenzocaine 20%Menthol 0.25%Benzalkonium Chloride 0.1%
Otc - Purpose
PurposeOral pain relieverOral pain relieverAntiseptic
Indications & Usage
- Usefor the temporary relief of pain due to toothachesto help protect against infection of minor oral irritation
- WarningsMethemoglobenemia 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)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energyAllergy 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
Otc - Do Not Use
- Do not usemore than directedfor more than 7 days unless told to do so by a dentist or doctorfor teethingin children under 2 years of age
Otc - Stop Use
- Stop use and ask a doctor ifswelling, rash or fever developsirritation, pain or redness persists or worsenssymptoms do not improve in 7 daysallergic reaction occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- Directionscut open tip of tube on score markadults and children 2 years of age and older: apply a small amount of the product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctorchildren between 2 and 12 years of age should be supervised in the use of this productchildren under 2 years of age: do not use
Other Safety Information
- Other informationdo not use if tip is cut prior to openingthis preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulteddo not use continuouslythis formula will stay in place for extended duration of reliefavoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Inactive ingredientscellulose gum, gelatin, methyl salicylate, mineral oil, pectin, polyethylene glycol, sodium saccharin
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