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 1.2mg 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.

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

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

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

Rx only in USA

Made in USA

Topical Anesthetic Gel for oral us

Bubblegum

Contains: Benzocaine 20% in a flavored aqueous bse

Net Contents: 30g

Pascal International

2929 NE Northup Way

Bellevue, WA 98004

425.827.4694

REF 15-350

SN72506/1115

Precaine B Bubble Gum Label

PRECAINE B BUBBLEGUM
benzocaine topical anesthetic gel

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10866-0088-1	30 g in 1 JAR; Type 0: Not a Combination Product	01/27/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/27/2016

Labeler - Pascal Company, Inc. (009260217)

Name	Address	ID/FEI	Business Operations
Establishment
Pascal Company, Inc.		009260217	manufacture(10866-0088)