PRECAINE B- benzocaine topical anesthetic gel

Precaine B by

Drug Labeling and Warnings

Precaine B by is a Prescription medication manufactured, distributed, or labeled by Pascal Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directoons

Application Directions:

For topical use only

For best results apply to previously dried oral mucosa with cotton swab or similar applicator for adequate control of pain

Removal of excess saliva during application minimizes dilution of the anesthetic and perimts maximum penetration

Not more than 1.2mg per Kg body weight per patient should be applied during a 24-hour period

Warnings

Warning:

Recommended dosage should not be exceeded due to possible side effects. Keep out of the reach of children. For professional use only. Do not use in the eyes. Avoid swallowing. Not for home or unsupervised consumer use. Not for use on children 2 and younger or pregnant or nursing women.

Contraindications

Contraindications:

Precaine is contraindicated in patients with known hypersensitivity to benzocaine or PABA.

Other Information

For product MSDS information, please go to www.pascaldental.com or contact Pascal directly

Store product between 60 degress F (16 degress C) and 86 degrees F (30 degress C)

Rx only in USA

Made in USA

Precaine B

Precaine B

Topical Anesthetic Gel for oral use

Strawberry

Contain: Benzocaine 20% in a flavored aqueous base

Net Contents 30g

Pascal International

2929 NE Northup Way

Bellevue, WA 98004

425.827.4694

REF 15-350

SN72505/0912

INGREDIENTS AND APPEARANCE

PRECAINE B 
benzocaine topical anesthetic gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10866-0087
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	221 mg  in 1 g

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10866-0087-1	30 g in 1 JAR; Type 0: Not a Combination Product	04/27/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/27/2009

Labeler - Pascal Company, Inc. (009260217)

Establishment
Name	Address	ID/FEI	Business Operations
Pascal Company, Inc.		009260217	manufacture(10866-0087)