20% Benzocaine Gel

SPL v7

SPL

SPL Set ID dd805400-26c5-4c18-ade2-821298233f9b

Route

DENTAL

Published

Effective Date 2025-01-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (220 mg)

Inactive Ingredients

Water Fd&c Blue No. 1 D&c Green No. 5 Fd&c Red No. 3 D&c Red No. 28 Fd&c Red No. 40 Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance

Color: red Color: green Color: pink Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 1963-02-19

Description

Drug Facts

Purpose

Oral Anesthetic

Medication Information

Purpose

Oral Anesthetic

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast feeding, ask a physician before use.

Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.
children under 2 years of age: do not use

Do Not Use

for more than 7 days unless directed by a physician. 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 physician promptly.
for teething
in children under 2 years of age

Allergy Alert

Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Other Information

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

Active Ingredients

Benzocaine 200 mg (in each g)

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Questions Or Comments?

800-645-2310 or darby.com

When Using This Product

Avoid contact with eyes. If contact occurs, flush with water.

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 the 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, gray or blue colored skin (cyanosis)
headache
rapid heart rate
shortness of breath
dizziness or lightheadedness
fatigue or lack of energy

Principal Display Panel 1 Oz Jar Label Mint

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Principal Display Panel 1 Oz Jar Label Cherry

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Principal Display Panel 1 Oz Jar Label Raspberry

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Principal Display Panel 1 Oz Jar Label Bubble Gum

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Principal Display Panel 1 Oz Jar Label Strawberry

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Principal Display Panel 1 Oz Jar Label Pina Colada

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a physician before use.

Purpose

Oral Anesthetic

Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.
children under 2 years of age: do not use

Do Not Use (Do not use)

for more than 7 days unless directed by a physician. 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 physician promptly.
for teething
in children under 2 years of age

Allergy Alert

Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Other Information (Other information)

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

Active Ingredients (Active ingredients)

Benzocaine 200 mg (in each g)

Inactive Ingredients (Inactive ingredients)

flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Questions Or Comments? (Questions or comments?)

800-645-2310 or darby.com

When Using This Product (When using this product)

Avoid contact with eyes. If contact occurs, flush with water.

Methemoglobinemia Warning (Methemoglobinemia warning)

pale, gray or blue colored skin (cyanosis)
headache
rapid heart rate
shortness of breath
dizziness or lightheadedness
fatigue or lack of energy

Principal Display Panel 1 Oz Jar Label Mint (PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Mint)

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Principal Display Panel 1 Oz Jar Label Cherry (PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Cherry)

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Principal Display Panel 1 Oz Jar Label Raspberry (PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Raspberry)

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Principal Display Panel 1 Oz Jar Label Bubble Gum (PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Bubble Gum)

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Principal Display Panel 1 Oz Jar Label Strawberry (PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Strawberry)

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Principal Display Panel 1 Oz Jar Label Pina Colada (PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Pina Colada)

DARBY ^®

DARBY DENTAL SUPPLY, LLC

20% Benzocaine Gel

Topical Anesthetic Gel

Net Contents: 1 oz

DARBY

QUALITY

CERTIFIED

Manufactured for:

Darby Dental Supply, LLC

Jericho, NY 11753

PEEL BACK to review drug facts

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "53414-9": "If pregnant or breast feeding, ask a physician before use.", "Purpose": "Oral Anesthetic", "Directions": "Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use", "Do not use": "for more than 7 days unless directed by a physician. 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 physician promptly. for teething in children under 2 years of age", "Allergy Alert": "Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.", "Other information": "Store at 59° - 86°F (15 - 30°C). Protect from freezing.", "Active ingredients": "Benzocaine 200 mg (in each g)", "Inactive ingredients": "flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.", "Questions or comments?": "800-645-2310 or darby.com", "When using this product": "Avoid contact with eyes. If contact occurs, flush with water.", "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 the 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, gray or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy", "PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Mint": "DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts", "PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Cherry": "DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts", "PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Raspberry": "DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts", "PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Bubble Gum": "DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts", "PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Strawberry": "DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts", "PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Pina Colada": "DARBY ® DARBY DENTAL SUPPLY, LLC 20% Benzocaine Gel Topical Anesthetic Gel Net Contents: 1 oz DARBY QUALITY CERTIFIED Manufactured for: Darby Dental Supply, LLC Jericho, NY 11753 PEEL BACK to review drug facts"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:23.007706 · Updated: 2026-03-14T23:07:05.651363