Precaine B Bubblegum

Manufacturer
Pascal Company, Inc.
Effective date
2020-01-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 20:31:55

Label at a glance#

ProductPrecaine B Bubblegum
Active ingredientBENZOCAINE
Label structure5 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Directions

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 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

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

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

Other Information

OTHER SAFETY INFORMATION

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

Precaine B

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Precaine B

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 LabelPrecaine B Bubble Gum Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10866-0088-12022-01-28C16284748780-1d6a99b39-ba52-a426-e053-dadaa90af4c2Precaine B Bubblegum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10866-0088-1Precaine B Bubblegum30 g in 1 JARGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10866-0088PRECAINE B BUBBLEGUM (BENZOCAINE TOPICAL ANESTHETIC) GEL [PASCAL COMPANY, INC.]4Legacy NDC, 1 package rows20200123_391b3893-7c5f-28ba-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10866-008810866-0088-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 934Z135WT9208IACT
BENZOCAINEU3RSY48JW5ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9cc0a56b-3b24-3e47-e053-2995a90a857f391b3893-7c5f-28ba-e054-00144ff8d46c2020-01-22WarningsExact identifier
spl id: 9cc0a56b-3b24-3e47-e053-2995a90a857f
spl set id: 391b3893-7c5f-28ba-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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