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
DISTRIBUTED BY TOPCO ASSOCIATES LLCELK GROVE VILLAGE, IL 60057QUESTIONS" firstname.lastname@example.org www.topcarebrand.com
Otc - Active Ingredient
Active ingredientBenzocaine 20%
Otc - Purpose
PurposeOral Pain Reliever
Indications & Usage
- Usefor the temporary relief of pain due to toothaches
- WarningsMethemoglobinemia 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, 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 scoremarkadults and children 2 years of age and older: apply a small amount of product to the cavity and around the 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 informationdo not use if tip is cut prior to openingthis preparation is intended for use in cases of toothache, only as a tempory expedient until a dentist can be consulteddo not use continuously
Inactive ingredients flavor, polyethylene glycol, sodium saccharin, sorbic acid
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