PRODIGIUM- benzocaine 10% liquid

Prodigium by

Drug Labeling and Warnings

Prodigium by is a Otc medication manufactured, distributed, or labeled by Price & Novelties, Inc, LEX, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: (%) Purpose

Benzocaine USP 10%..................Oral Anesthetic

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

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

Do not use:

• for more than 7 days unless directed by a dentist or doctor.
• For teething
• in children under 2 years of age

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

QUESTIONS

Questions or comments?

787-781-3352

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

Prodigium

INGREDIENTS AND APPEARANCE

PRODIGIUM 
benzocaine 10% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54361-7020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	10 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54361-7020-1	4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product	07/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	07/01/2024

Labeler - Price & Novelties, Inc (091061523)

Establishment
Name	Address	ID/FEI	Business Operations
LEX, Inc		046172888	manufacture(54361-7020)