BENZ O STHETIC- benzocaine spray

Benz O Sthetic by

Drug Labeling and Warnings

Benz O Sthetic by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drugs Facts

Active Ingredients                       Purpose
Benzocaine 20%........................Oral Anesthetic

Uses

Topical anesthetic for the temporary relief of occasional minor irritation and pain, associated with:
canker sores

• sore mouth and throat
• minor dental procedures
• minor irritation of the mouth and gums caused by dentures or orthodontic appliances
• minor injury of the mouth and gums

Directions

May be used with extension tube for finer direct application. For adults and children 2 years and older anesthetic use in mouth or throat:
Pump spray 2-3 times up to 4 times. Repeat if needed for larger areas. Anesthetic effect is reached in 15-30 seconds. Children under 12 years of age should be supervised and use as directed by dentist/doctor.

INDICATIONS & USAGE

Warnings

Do not use this product if patient has a history of allergy to local anesthetics
such as procaine, butacaine, benzocaine, or other “caine” anesthetics. Do not
spray into or near eyes. Do not inhale.

Patient: When using extension tube, do not spray in the back of the throat
unless your dentist or doctor directed you to do so.

When using this product:

• Avoid use near eyes
• Do not use more than recommended dosage
• Do not go beyond 7 days usage, unless directed by your doctor/dentist

Patient: Discontinue use and consult a physician if: sore mouth symptoms do
not improve in 5 days; irritation, pain, or redness persists or worsens;
swelling, rash, or fever develops.

Other Ingredients

Alcohol, benzyl alcohol, flavor, peppermint oil, polyethylene glycol, sodium saccharin

Other Information:

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

WARNINGS AND PRECAUTIONS

Caution:​ ​If accidental or excessive ingestion occurs (exceeds recommended dosage) contact a physician for immediate advice or call a Poison Control Center. 

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZ O STHETIC 
benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-929
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	11.8 g  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PEPPERMINT OIL (UNII: AV092KU4JH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (CHERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-929-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/30/2017

Labeler - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-929)