PRECAINE B CHOCOLATE VANILLA- benzocaine topical anesthetic gel 
Pascal Company, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Precaine B Chocolate Vanilla

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 LabelPrecaine 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

PRECAINE B CHOCOLATE VANILLA 
benzocaine topical anesthetic gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0089
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE221 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208) 125 mg  in 1 g
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorVANILLA, CHOCOLATEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10866-0089-130 g in 1 JAR; Type 0: Not a Combination Product08/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/16/2017
Labeler - Pascal Company, Inc. (009260217)
Establishment
NameAddressID/FEIBusiness Operations
Pascal Company, Inc.009260217manufacture(10866-0089)

Revised: 1/2020
Document Id: 9cc0c4ef-0922-e067-e053-2a95a90a321c
Set id: 5c630601-5060-1d77-e053-2a91aa0a00b7
Version: 2
Effective Time: 20200122
 
Pascal Company, Inc.