BENZOCAINE CHERRY- benzocaine gel BENZOCAINE MINT- benzocaine gel BENZOCAINE BUBBLE GUM- benzocaine gel BENZOCAINE STRAWBERRY- benzocaine gel BENZOCAINE RASPBERRY- benzocaine gel BENZOCAINE PINA COLADA- benzocaine gel

BENZOCAINE by

Drug Labeling and Warnings

BENZOCAINE by is a Otc medication manufactured, distributed, or labeled by Darby Dental Supply, LLC, DSHealthcare, Keystone Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Benzocaine 200 mg (in each g)

Purpose

Oral Anesthetic

Use

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

Warnings

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

Allergy Alert

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

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

When using this product

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

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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

Keep out of reach of children.

Directions

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

Other information

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

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

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 - 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 - 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 - 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 - 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

INGREDIENTS AND APPEARANCE

BENZOCAINE  CHERRY
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66467-4002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66467-4002-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/19/1963

BENZOCAINE  MINT
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66467-4003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66467-4003-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/19/1963

BENZOCAINE  BUBBLE GUM
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66467-4001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66467-4001-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/19/1963

BENZOCAINE  STRAWBERRY
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66467-4006
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66467-4006-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/19/1963

BENZOCAINE  RASPBERRY
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66467-4000
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66467-4000-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/19/1963

BENZOCAINE  PINA COLADA
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66467-4004
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	WHITE (DYE FREE)	Score
Shape		Size
Flavor	COCONUT (Pina Colada)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66467-4004-2	30 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/19/1963

Labeler - Darby Dental Supply, LLC (825137818)

Registrant - DSHealthcare (056296981)

Establishment
Name	Address	ID/FEI	Business Operations
Keystone Industries		014769301	MANUFACTURE(66467-4000, 66467-4001, 66467-4002, 66467-4003, 66467-4004, 66467-4006)