LOLLICAINE BUBBLE GUM- benzocaine gel, dentifrice LOLLICAINE CHERRY- benzocaine gel, dentifrice LOLLICAINE MINT- benzocaine gel, dentifrice LOLLICAINE PINA COLADA- benzocaine gel, dentifrice

LolliCaine Pina Colada by

Drug Labeling and Warnings

LolliCaine Pina Colada by is a Otc medication manufactured, distributed, or labeled by Centrix, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Benzocaine 20%

Purpose

Oral Anesthetic

Use

LolliCaine is a flavored topical anesthetic gel featuring rapid onset, no systemic absorption and a 15 minute duration. LolliCaine is packaged in a 1-oz. jar.

For the temporary relief of occasional minor irritation and pain, associated with:

• Sore mouth and throat
• Ulcers
• Minor dental procedures
• Needle punctures
• Minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

For external use only

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, 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 if you have a history of allergy to any “caine” anesthetics, such as benzocaine, butacaine, procaine or tetracaine.

Sore Throat Warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

Do Not Use

• for teething
• in children under 2 years of age

When using this product

avoid contact with eyes

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center right away.

Directions

Use appropriate applicator and apply gel to mucosa or gingival soft tissue. Wait one minute or until tissue feels numb before starting needle injection or other procedure. Do not exceed recommended dosage.

Adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by dentist or doctor.

Children under 12 years of age: should be supervised in the use of the product.

Children under 2 years of age: do not use

Other information

Store at 59° to 86º F (15º to 30º C)

Inactive ingredients

Blue 1*, flavor, PEG-8, PEG-75, Red 3*, Red 33*, Red 40*, sodium saccharin, Yellow 10*

*contains one or more of these ingredients.

Questions or comments?

CENTRIX INCORPORATED
770 River Road, Shelton CT 06484 USA
Toll Free (USA): (800) 235-5862
Tel: (203) 929-5582 Fax: (203) 929-6804
www.centrixdental.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOLLICAINE BUBBLE GUM 
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60640-1700
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

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: 60640-1700-1	1 in 1 CARTON	08/27/2019
1		28.35 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/27/2019

LOLLICAINE CHERRY 
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60640-1800
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)

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: 60640-1800-1	1 in 1 CARTON	08/27/2019
1		28.35 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/27/2019

LOLLICAINE MINT 
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60640-1900
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

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: 60640-1900-1	1 in 1 CARTON	08/27/2019
1		28.35 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/27/2019

LOLLICAINE PINA COLADA 
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60640-2000
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	COCONUT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60640-2000-1	1 in 1 CARTON	08/27/2019
1		28.35 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/27/2019

Labeler - Centrix, Inc. (053707303)

Establishment
Name	Address	ID/FEI	Business Operations
Centrix, Inc.		053707303	repack(60640-1700, 60640-1800, 60640-1900, 60640-2000)