PRECAINE B CHOCOLATE VANILLA- benzocaine topical anesthetic gel

Precaine B Chocolate Vanilla by

Drug Labeling and Warnings

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

Drug Details [pdf]

Directions:

Application Directions:

For topical use only.

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

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

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

Warnings

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

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

Other Information

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

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

Rx only in USA

Made in USA

Precaine B Chocolate Vanilla

Precaine B

Topical Anesthetic Gel for oral use

Chocolate Vanilla

Contains: Benzocaine 20% in a flavored aqueous base

Net contents: 30g

Pascal International

2929 Northup Way

Bellevue, WA 98004

425-827-4694

REF 15-365

SN72508/0217

INGREDIENTS AND APPEARANCE

PRECAINE B CHOCOLATE VANILLA 
benzocaine topical anesthetic gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10866-0089
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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)	125 mg  in 1 g

Product Characteristics
Color	green	Score
Shape		Size
Flavor	VANILLA, CHOCOLATE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10866-0089-1	30 g in 1 JAR; Type 0: Not a Combination Product	08/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/16/2017

Labeler - Pascal Company, Inc. (009260217)

Establishment
Name	Address	ID/FEI	Business Operations
Pascal Company, Inc.		009260217	manufacture(10866-0089)