FDA Label for Benz O Sthetic

The following document was submitted to the FDA by the labeler of this product Geritrex Corp.. 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.

Drugs Facts

Active Ingredients PurposeBenzocaine 20% Oral Anesthetic

Uses

For control of pain; Topical anesthetic for oral or mucosal areas. Tosuppress the gag reflex.

Directions

May be used with extension tube for finer direct application. For anestheticuse in mouth or throat: pump spray 2-3 times or as needed. Repeat if neededfor larger areas. Anesthetic effect is reached in 15-30 seconds.

Dosage & Administration

Children under 6yrs of age use as directed by dentist/doctor.

Warnings

Do not use this product if patient has a history of allergy to local anestheticssuch as procaine, butacaine, benzocaine, or other “caine” anesthetics. Do notspray into or near eyes. Do not inhale.Patient: When using extension tube, do not spray in the back of the throatunless your dentist or doctor directed you to do so.When using this product:Π Avoid use near eyes Π Do not use more than recommended dosageΠ Do not go beyond 7 days usage, unless directed by your doctor/dentistPatient: Discontinue use and consult a physician if: sore mouth symptoms donot improve in 5 days; irritation, pain, or redness persists or worsens;swelling, rash, or fever develops.

Other Ingredients

Benzyl alcohol, flavor, polyethylene glycol, SDA38B,Sodium Saccharine

Storage

Store at controlled room temperature 20-25°C (68-77°F)

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.Principal Display Panel

Label of Bottle - BESP2

Enter section text here

* Please review the disclaimer below.