FDA.reportPublic FDA data

VistaCaine Topical Anesthetic

Manufacturer
Inter-Med, INC.
Effective date
2022-01-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:29

Label at a glance#

ProductVistaCaine Topical Anesthetic
Active ingredientBENZOCAINE
Label structure10 sections

Dosage and administration

Apply only amount needed to the oral mucosa to prevent or relieve pain.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 200 mg

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Use

INDICATIONS & USAGE SECTION

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Warnings

WARNINGS SECTION

  • ​Allergy Alert:​ Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
  • ​Do Not Use​ for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
  • ​When using this product​ avoid contact with eyes. If contact occurs, flush with water.
  • ​Stop use and consult a health care practitioner​ if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
  • ​Do not exceed recommended dosage.​ If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
  • ​If pregnant or breast feeding, ​ask a health professional before use. 

​Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

​Directions

DOSAGE & ADMINISTRATION SECTION

Apply only amount needed to the oral mucosa to prevent or relieve pain.

​Other Information

STORAGE AND HANDLING SECTION

Store at 59º -86°F (15 - 30°C).

Protect from freezing.

​Inactive ingredients

INACTIVE INGREDIENT SECTION

​flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #5, red #3, red #28, red #40, yellow #5 (tartrazine), as a color additive.

Questions or comments?

OTC - QUESTIONS SECTION

1-262-636-9755

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LB.Vista Topical Wrap_R7.jpgLB.Vista Topical Wrap_R7.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN2
2002727VistaCaine 200 MG/GM Oral GelPSN2
2002727benzocaine 0.2 MG/MG Oral Gel [Vistacaine]SBD2
238910benzocaine 0.2 MG/MG Oral GelSCD2
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY2
2002727Vistacaine 0.2 MG/MG Oral GelSY2
2002727Vistacaine 200 MG/GM Oral GelSY2

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
64522-002-302025-01-30C16284748780-12cef2736-9bf9-d83d-e063-dadaa90ab31f34a99087-3423-4e85-93e5-89d2f504528b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64522-002-30VistaCaine Topical Anesthetic30 g in 1 JARGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64522-002VISTACAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [INTER-MED, INC.]2Legacy NDC, 1 package rows20220125_34a99087-3423-4e85-93e5-89d2f504528b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64522-00264522-002-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C GREEN NO. 58J6RDU8L9XIACT
FD&C RED NO. 3PN2ZH5LOQYIACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 40WZB9127XOAIACT
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
d658b63c-d2bc-1438-e053-2a95a90a9f8734a99087-3423-4e85-93e5-89d2f504528b2022-01-24WarningsExact identifier
spl id: d658b63c-d2bc-1438-e053-2a95a90a9f87
spl set id: 34a99087-3423-4e85-93e5-89d2f504528b

Reported adverse events (FAERS/openFDA)#

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