Scott's Select Topical Anesthetic Gel

Manufacturer
Scott's Dental Supply LLC
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:33:53

Label at a glance#

ProductScotts Select Topical Anesthetic
Active ingredientBenzocaine
Label structure9 sections

Indications and uses

For the temporary relief of pain associated with canker sores and minor dental procedures.

Dosage and administration

Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product. Children under 2 years of age: Consult a dentist or doctor.

Storage and handling

Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine, 20%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain associated with canker sores and minor dental procedures.

Warnings

WARNINGS SECTION

Allergy Alert

SPL UNCLASSIFIED SECTION

Do Not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.

OTC - DO NOT USE SECTION

Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

Do not exceed recommended dosage.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
  • Children under 12 years of age should be supervised in the use of this product.
  • Children under 2 years of age: Consult a dentist or doctor.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 59 - 86 °F (15 - 30 °C). Protect from freezing and heat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C Red # 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol.

PRINCIPAL DISPLAY PANEL - 32 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Scott's
SELECT ✓

TOPICAL ANESTHETIC GEL
With Vitamin E and Xylitol • Gluten Free

REORDER 972-4405

1.12 OZ (32g)

BUBBLE GUM

Peel Here

PRINCIPAL DISPLAY PANEL - 32 g Bottle Label
PRINCIPAL DISPLAY PANEL - 32 g Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69638-060-322022-01-28C16284748780-1d6a99b39-5692-a426-e053-dadaa90af4c2Scott's Select Topical Anesthetic Gel

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69638-06069638-060-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML · Source PDF

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
8a3b8909-dd8f-4272-8bf8-88d16b253eb8933f02a8-aaab-4e7e-945f-644c476ece782020-04-27WarningsExact identifier
spl id: 8a3b8909-dd8f-4272-8bf8-88d16b253eb8
spl set id: 933f02a8-aaab-4e7e-945f-644c476ece78

Reported adverse events (FAERS/openFDA)#

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