FDA.reportPublic FDA data

Precaine Anesthetic Gel

Manufacturer
Pascal Company, Inc. | Elizabeth Williams
Effective date
2025-12-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 21:49:31

Label at a glance#

ProductPrecaine
Active ingredientLIDOCAINE, DIBUCAINE
Label structure6 sections

Label contents#

Full prescribing information#

DOSAGE FORMS & STRENGTHS SECTION

Contains: Lidocaine 8%, Dibucaine 0.8%

In a flavored aqueous base.

Net Contents 30g

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 permits maximum penetration.
  • Not more than one ounce (28g) per patient should be applied during a 24 hour period.

WARNINGS SECTION

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.

CONTRAINDICATIONS SECTION

Precaine is contraindicated in patients with known hypersensitivity to amine or quinoline type anesthetics.

OTHER SAFETY INFORMATION

For product MSDS information please go to www.pascaldental.com or contact Pascal directly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Precaine

Topical Anesthetic Gel for oral use

Strawberry

Precaine Strawberry LabelPrecaine Strawberry Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIBUCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10866-0062-12025-02-27C16284748780-11030e365-3401-111a-e063-dadaa90a10e2Precaine Anesthetic Gel
10866-0062-12024-01-30C16284748780-11030e365-3401-111a-e063-dadaa90a10e2Precaine Anesthetic Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10866-0062-1Precaine30 g in 1 JARGEL308

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIBUCAINEACTIVE INGREDIENTL6JW2TJG991
LIDOCAINEACTIVE INGREDIENT98PI2009871
DIBUCAINEACTIVE MOIETYL6JW2TJG991
LIDOCAINEACTIVE MOIETY98PI2009871

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
10866-006210866-0062-1

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
LIDOCAINE98PI200987ACTIB
DIBUCAINEL6JW2TJG99ACTIB

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
45a11840-0cb1-bd83-e063-6394a90afa3913c66e6e-b617-1cf3-e054-00144ff88e882025-12-10WarningsExact identifier
spl id: 45a11840-0cb1-bd83-e063-6394a90afa39
spl set id: 13c66e6e-b617-1cf3-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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