FDA.reportPublic FDA data

SmartPractice topical anesthetic gel

Manufacturer
SmartHealth, Inc. (DBA SmartPractice) | Dentsply Caulk
Effective date
2017-12-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:25:14

Label at a glance#

ProductSmartPractice topical anesthetic gel Pina Colada
Active ingredientBENZOCAINE
Label structure14 sections

Dosage and administration

1. Each gram of benzocaine gel between 180-220mg benzocaine in a flavored base. 2. Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle. 3. For topical tissue anesthesia during scaling procedures, dispense a small amount of gel into a dappen dish, then coat the scaler with the product prior to use. 4. Tightl...

Storage and handling

Store between 59°-86°F (15°-30°C). Protect from freezing.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.

INDICATIONS

INDICATIONS & USAGE SECTION

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra- oral radiographs.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Should not be used with individuals with a known sensitivity to benzocaine or PABA.

WARNINGS

WARNINGS SECTION

Keep out of reach of children. For professional dental use only.

PRECAUTIONS

PRECAUTIONS SECTION

SmartPractice 20% benzocaine gels are supplied in multiple use containers. Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

1. Each gram of benzocaine gel between 180-220mg benzocaine in a flavored base.

2. Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle.

3. For topical tissue anesthesia during scaling procedures, dispense a small amount of gel into a dappen dish, then coat the scaler with the product prior to use.

4. Tightly re-cap the jar after each use.

STORAGE

STORAGE AND HANDLING SECTION

Store between 59°-86°F (15°-30°C). Protect from freezing.

DISTRIBUTED BY

SPL UNCLASSIFIED SECTION

distributed by:
SmartPractice

3400 east mcdowell rd

phoenix, AZ 85008

Made in USA.

PRINCIPAL DISPLAY PANEL - Cherry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cherry bottlecherry bottle

PRICIPAL DISPLAY PANEL - Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mintmint

PRINCIPAL DISPLAY PANEL - Pina Colada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pina coladapina colada

PRINCIPAL DISPL;AY PANEL - Bubble Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bubble gumbubble gum

PRINCIPAL DISPLAY PANEL - Strawberry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

strawberrystrawberry

PRINCIPAL DISPLAY PANEL - Raspberry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

raspberryraspberry

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN1
238910benzocaine 0.2 MG/MG Oral GelSCD1
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69521-011-342020-01-31C16284748780-19d75b9cf-ec8d-f424-e053-dadaa90a57ceSmartPractice topical anesthetic gel
69521-021-342020-01-31C16284748780-19d75b9cf-ec8d-f424-e053-dadaa90a57ceSmartPractice topical anesthetic gel
69521-031-342020-01-31C16284748780-19d75b9cf-ec8d-f424-e053-dadaa90a57ceSmartPractice topical anesthetic gel
69521-041-342020-01-31C16284748780-19d75b9cf-ec8d-f424-e053-dadaa90a57ceSmartPractice topical anesthetic gel
69521-051-342020-01-31C16284748780-19d75b9cf-ec8d-f424-e053-dadaa90a57ceSmartPractice topical anesthetic gel
69521-061-342020-01-31C16284748780-19d75b9cf-ec8d-f424-e053-dadaa90a57ceSmartPractice topical anesthetic gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69521-011-34SmartPractice topical anesthetic gelMint34 g in 1 BOTTLE, PLASTICGEL341
69521-021-34SmartPractice topical anesthetic gelCherry34 g in 1 BOTTLE, PLASTICGEL341
69521-031-34SmartPractice topical anesthetic gelBubble Gum34 g in 1 BOTTLE, PLASTICGEL341
69521-041-34SmartPractice topical anesthetic gelPina Colada34 g in 1 BOTTLE, PLASTICGEL341
69521-051-34SmartPractice topical anesthetic gelStrawberry34 g in 1 BOTTLE, PLASTICGEL341
69521-061-34SmartPractice topical anesthetic gelRaspberry34 g in 1 BOTTLE, PLASTICGEL341

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69521-011SMARTPRACTICE TOPICAL ANESTHETIC GEL PINA COLADA (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL BUBBLE GUM (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL STRAWBERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL CHERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL MINT (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL RASPBERRY (BENZOCAINE) GEL [SMARTHEALTH, INC. (DBA SMARTPRACTICE)]1Legacy NDC, 1 package rows20171229_616aa460-7857-9f4d-e053-2a91aa0a5d58.zip
69521-021SMARTPRACTICE TOPICAL ANESTHETIC GEL PINA COLADA (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL BUBBLE GUM (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL STRAWBERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL CHERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL MINT (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL RASPBERRY (BENZOCAINE) GEL [SMARTHEALTH, INC. (DBA SMARTPRACTICE)]1Legacy NDC, 1 package rows20171229_616aa460-7857-9f4d-e053-2a91aa0a5d58.zip
69521-031SMARTPRACTICE TOPICAL ANESTHETIC GEL PINA COLADA (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL BUBBLE GUM (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL STRAWBERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL CHERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL MINT (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL RASPBERRY (BENZOCAINE) GEL [SMARTHEALTH, INC. (DBA SMARTPRACTICE)]1Legacy NDC, 1 package rows20171229_616aa460-7857-9f4d-e053-2a91aa0a5d58.zip
69521-041SMARTPRACTICE TOPICAL ANESTHETIC GEL PINA COLADA (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL BUBBLE GUM (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL STRAWBERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL CHERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL MINT (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL RASPBERRY (BENZOCAINE) GEL [SMARTHEALTH, INC. (DBA SMARTPRACTICE)]1Legacy NDC, 1 package rows20171229_616aa460-7857-9f4d-e053-2a91aa0a5d58.zip
69521-051SMARTPRACTICE TOPICAL ANESTHETIC GEL PINA COLADA (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL BUBBLE GUM (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL STRAWBERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL CHERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL MINT (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL RASPBERRY (BENZOCAINE) GEL [SMARTHEALTH, INC. (DBA SMARTPRACTICE)]1Legacy NDC, 1 package rows20171229_616aa460-7857-9f4d-e053-2a91aa0a5d58.zip
69521-061SMARTPRACTICE TOPICAL ANESTHETIC GEL PINA COLADA (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL BUBBLE GUM (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL STRAWBERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL CHERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL MINT (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL RASPBERRY (BENZOCAINE) GEL [SMARTHEALTH, INC. (DBA SMARTPRACTICE)]1Legacy NDC, 1 package rows20171229_616aa460-7857-9f4d-e053-2a91aa0a5d58.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69521-04169521-041-34
69521-01169521-011-34
69521-02169521-021-34
69521-03169521-031-34
69521-05169521-051-34
69521-06169521-061-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
D&C RED NO. 28767IP0Y5NHIACT
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
PEPPERMINT OILAV092KU4JHIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
D&C GREEN NO. 58J6RDU8L9XIACT
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
BENZOCAINEU3RSY48JW5ACTIB
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
616aa460-7858-9f4d-e053-2a91aa0a5d58616aa460-7857-9f4d-e053-2a91aa0a5d582017-12-28WarningsExact identifier
spl id: 616aa460-7858-9f4d-e053-2a91aa0a5d58
spl set id: 616aa460-7857-9f4d-e053-2a91aa0a5d58

Reported adverse events (FAERS/openFDA)#

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