Drugs Facts
Active Ingredients PurposeBenzocaine 20% Oral Anesthetic
Benz O Sthetic
FDA Label NDC 54162-925
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Corp. for the product Benz O Sthetic (NDC 54162-925). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drugs facts, uses, directions, dosage & administration, warnings, other ingredients, storage, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
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