PRECAINE B- 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

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

Precaine B Label

PRECAINE B 
benzocaine topical anesthetic gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0087
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE221 mg  in 1 g
Product Characteristics
ColorredScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10866-0087-130 g in 1 JAR; Type 0: Not a Combination Product04/27/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/27/2009
Labeler - Pascal Company, Inc. (009260217)
Establishment
NameAddressID/FEIBusiness Operations
Pascal Company, Inc.009260217manufacture(10866-0087)

Revised: 12/2022
Document Id: f03928f8-ca55-60c2-e053-2995a90a6150
Set id: 1a4c0efc-bcfd-671f-e054-00144ff88e88
Version: 3
Effective Time: 20221219
 
Pascal Company, Inc.