LOLLICAINE BUBBLE GUM- benzocaine gel, dentifrice LOLLICAINE CHERRY- benzocaine gel, dentifrice LOLLICAINE MINT- benzocaine ge

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Benzocaine 20%
Available from:
Centrix, Inc.
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Oral Anesthetic 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 - 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.
Authorization status:
OTC monograph not final
Authorization number:
60640-1700-1, 60640-1800-1, 60640-1900-1, 60640-2000-1

LOLLICAINE BUBBLE GUM- benzocaine gel, dentifrice

LOLLICAINE CHERRY- benzocaine gel, dentifrice

LOLLICAINE MINT- benzocaine gel, dentifrice

LOLLICAINE PINA COLADA- benzocaine gel, dentifrice

Centrix, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lollicaine Topical Anesthetic Gel/Liquid –

20% Benzocaine

Active ingredients

Benzocaine 20%

Purpos e

Oral Anesthetic

Us e

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

dos age.

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

LOLLICAINE BUBBLE GUM

benzocaine gel, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 6 40 -170 0

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

20 0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYETHYLENE GLYCO L 3 3 50 (UNII: G2M7P15E5P)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

FD&C RED NO . 3 (UNII: PN2ZH5LOQY)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

Product Characteristics

Color

pink

S core

S hap e

S iz e

Flavor

BUBBLE GUM

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 6 40 -170 0 -1

1 in 1 CARTON

0 8 /27/20 19

1

28 .35 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 8 /27/20 19

LOLLICAINE CHERRY

benzocaine gel, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 6 40 -18 0 0

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

20 0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYETHYLENE GLYCO L 3 3 50 (UNII: G2M7P15E5P)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Product Characteristics

Color

re d

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 6 40 -18 0 0 -1

1 in 1 CARTON

0 8 /27/20 19

1

28 .35 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 8 /27/20 19

LOLLICAINE MINT

benzocaine gel, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 6 40 -19 0 0

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

20 0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYETHYLENE GLYCO L 3 3 50 (UNII: G2M7P15E5P)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

FD&C RED NO . 3 (UNII: PN2ZH5LOQY)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

Product Characteristics

Color

gre e n

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 6 40 -19 0 0 -1

1 in 1 CARTON

0 8 /27/20 19

1

28 .35 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 8 /27/20 19

LOLLICAINE PINA COLADA

benzocaine gel, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 6 40 -20 0 0

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

20 0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYETHYLENE GLYCO L 3 3 50 (UNII: G2M7P15E5P)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

Product Characteristics

Color

ye llo w

S core

S hap e

S iz e

Flavor

COCONUT

Imprint Code

Centrix, Inc.

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 6 40 -20 0 0 -1

1 in 1 CARTON

0 8 /27/20 19

1

28 .35 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 8 /27/20 19

Labeler -

Centrix, Inc. (053707303)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Centrix, Inc.

0 5370 730 3

repack(6 0 6 40 -170 0 , 6 0 6 40 -18 0 0 , 6 0 6 40 -19 0 0 , 6 0 6 40 -20 0 0 )

Revised: 9/2019

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