Precaine B

Manufacturer: Pascal Company, Inc.
Effective date: 2022-12-19
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:45:43

Label at a glance#

ProductPrecaine B

Active ingredientBENZOCAINE

Label structure5 sections

Contacts and useful links#

PhoneLabel contact425.827.4694

Websitewww.pascaldental.com

www.pascaldental.com

Label contents#

Full prescribing information#

Directoons

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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 SECTION

Contraindications:

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

Other Information

OTHER SAFETY 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10866-0087-1	2024-01-30	C162847	48780-1	d6a99b39-3849-a426-e053-dadaa90af4c2	Precaine B
10866-0087-1	2022-12-19	C162847	48780-1	d6a99b39-3849-a426-e053-dadaa90af4c2	Precaine B
10866-0087-1	2022-01-28	C162847	48780-1	d6a99b39-3849-a426-e053-dadaa90af4c2	Precaine B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10866-0087-1	Precaine B	30 g in 1 JAR	GEL	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10866-0087	PRECAINE B (BENZOCAINE TOPICAL ANESTHETIC) GEL [PASCAL COMPANY, INC.]	3	Legacy NDC, 1 package rows	20221221_1a4c0efc-bcfd-671f-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

Precaine B
Benzocaine Topical Anesthetic
BENZOCAINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10866-0087	10866-0087-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f03928f8-ca55-60c2-e053-2995a90a6150			1a4c0efc-bcfd-671f-e054-00144ff88e88	2022-12-19	Warnings	Exact identifier spl id: f03928f8-ca55-60c2-e053-2995a90a6150 spl set id: 1a4c0efc-bcfd-671f-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.