Label: BENZOCAINE MINT- benzocaine gel
BENZOCAINE BUBBLE GUM- benzocaine gel
BENZOCAINE RASPBERRY- benzocaine gel
BENZOCAINE PINA COLADA- benzocaine gel
- NDC Code(s): 66467-4000-2, 66467-4001-2, 66467-4003-2, 66467-4004-2
- Packager: Darby Dental Supply, LLC
- 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 July 3, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
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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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Cherry
- PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Mint
- PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Bubble Gum
- PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Strawberry
- PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Raspberry
- PRINCIPAL DISPLAY PANEL - 1 oz Jar Label - Pina Colada
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INGREDIENTS AND APPEARANCE
BENZOCAINE MINT
benzocaine gelProduct 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 07/03/2023 BENZOCAINE BUBBLE GUM
benzocaine gelProduct 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 07/03/2023 BENZOCAINE RASPBERRY
benzocaine gelProduct 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 gelProduct 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 07/03/2023 Labeler - Darby Dental Supply, LLC (825137818) Registrant - DSHealthcare (056296981) Establishment Name Address ID/FEI Business Operations Keystone Industries 014769301 manufacture(66467-4001, 66467-4003, 66467-4000, 66467-4004)
