FDA.reportPublic FDA data

Topicale Gel Jar

Manufacturer
Medical Products Laboratories, Inc.
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:28

Label at a glance#

ProductTopicale
Active ingredientBENZOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 18%

OTC - PURPOSE SECTION

Oral Anesthetic

INDICATIONS & USAGE SECTION

For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by dentures or orthodontic appliances

WARNINGS SECTION

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops pale, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy.

Contraindications:

Do not use in large quantities or over large areas of body

Do not use for Teething

Do not use in children under 2 years of age

Allergy Alert:

Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other "caine" anesthetics

When using this product

  • Avoid contact with eyes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Centre immediately.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting
If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens

DOSAGE & ADMINISTRATION SECTION

Do not use more than directed.

Adults and children 12 years or older - Apply to the affected area. Allow to remain in place at least one minute and the spit out. Use up to 4 times daily or as directed by a dentist or doctor.

Children 2-12 years of age - Should be supervised in the use of the product.

Children under 2 years of age - Do not use.

OTHER SAFETY INFORMATION

  • Do not use if imprinted seal under cap is broken or missing
  • Store at 68º to 77º F (20º - 25º C)

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride (as a preservative), D&C Red Dye # 33, Flavorings, Polyethylene Glycol, Saccharin Sodium.

INFORMATION FOR OWNERS/CAREGIVERS SECTION

NDC 10733-166-35

Premier

Topicale

Topical Anesthetic Gel

Benzocaine, 18 %

REF 9007161 35g Jar

Tropical Fruit

Made in U.S.A.

Manufactured for: Premier® Dental Products Company,

1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A.

Mfg: Medical Products Laboratories, Inc.

9990 Global Road Philadelphia, PA 19115 U.S.A.

0518005 Rev3 MPL 317931

Questions or Comments?

888.670.6100 or 610.239.6000

M-Th: 7:30a.m. - 5:30p.m., F: 7:30a.m. - 4:00p.m. EST

To obtain an SDS, contact Customer Service Department or visit www.premusa.com.

Retain drug facts for future reference.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncartonlabel jarlabel jar

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1042838benzocaine 18 % Oral GelPSN4
1049213Topicale 18 % Oral GelPSN4
1049213benzocaine 0.18 MG/MG Oral Gel [Topicale]SBD4
1042838benzocaine 0.18 MG/MG Oral GelSCD4
1042838benzocaine 18 % Oral GelSY4
1049213Topicale 0.18 MG/MG Oral GelSY4
1049213Topicale 18 % Oral GelSY4

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10733-166-35Topicale35 g in 1 CARTONGEL354

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10733-166TOPICALE (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.]4Current NDC, 1 package rows20241213_826eaef8-4457-3dc2-e053-2991aa0a528b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10733-166-35GM - Gram10733-166ff2ab993-1d67-408b-9c76-753f0b81309212022-06-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10733-16610733-166-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
SACCHARIN SODIUMSB8ZUX40TYIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
D&C RED NO. 339DBA0SBB0LIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

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
TopicaleBENZOCAINEMedical Products Laboratories, Inc.826eaef8-4457-3dc2-e053-2991aa0a528b2024-12-11WarningsExact identifier
ndc (package): 10733-166-35
ndc (product): 10733-166
ndc11 (package): 10733016635
spl id: 28dd05fd-da61-a52d-e063-6394a90afe83
spl set id: 826eaef8-4457-3dc2-e053-2991aa0a528b

Reported adverse events (FAERS/openFDA)#

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