Label: LOLLICAINE BUBBLE GUM- benzocaine gel, dentifrice
LOLLICAINE CHERRY- benzocaine gel, dentifrice
LOLLICAINE MINT- benzocaine gel, dentifrice
LOLLICAINE PINA COLADA- benzocaine gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 60640-1700-1, 60640-1800-1, 60640-1900-1, 60640-2000-1 - Packager: Centrix, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
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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
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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
- Keep out of reach of children.
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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
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LOLLICAINE BUBBLE GUM
benzocaine gel, dentifriceProduct 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, dentifriceProduct 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, dentifriceProduct 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, dentifriceProduct 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)
