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 Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drugs Facts

Active Ingredients Purpose
Benzocaine 20% Oral Anesthetic

Uses

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

Directions

May be used with extension tube for finer direct application. For anesthetic
use in mouth or throat: pump spray 2-3 times or as needed. Repeat if needed
for 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 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:
Π Avoid use near eyes Π Do not use more than recommended dosage
Π 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

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

BENZ O STHETIC 
benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-925
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE (UNII: 3X5A8DP6HC)
SACCHARIN SODIUM DIHYDRATE (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: 54162-925-02	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/13/2012

Labeler - Geritrex Corp. (112796248)