FDA Label for Prodigium
View Indications, Usage & Precautions
Prodigium Product Label
The following document was submitted to the FDA by the labeler of this product Price & Novelties, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients: (%) Purpose
Benzocaine USP 10%..................Oral Anesthetic
Otc - Purpose
Purpose
Oral Anesthetic
Indications & Usage
Uses
For temporary relief of pain associated with the following mouth and gum irritations:
- toothache
- sore gums
- cranker sores
- braces
- minor dental procedures
Warnings
Warnings
Do not exceed recommended dosage
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 the 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
- do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.
Allergy alert
Otc - Do Not Use
Do not use:
- for more than 7 days unless directed by a dentist or doctor.
- For teething
- in children under 2 years of age
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. If pregnant or breastfeeding, ask a health professional before use.
Dosage & Administration
Directions
•adults and children over 12 years of age apply to the affected area. Gargle, swish around the mouth or allow to remain in place at least 1 minute and then spit out. 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 the product • Children under 2 years of age: Consult a dentist or doctor
Inactive Ingredient
Inactive Ingredients:
polyethylene glycol
Otc - Questions
Questions or comments?
787-781-3352
Otc - Stop Use
Stop use and consult a doctor promptly if:
- symptoms do not improve in 7 days
- swelling, rash, or fever develop
- irritation, pain, or redness persist or worsen
- symptoms persist for more than 7 days
- allergic reaction occurs
* Please review the disclaimer below.
