Label: SMARTPRACTICE TOPICAL ANESTHETIC GEL PINA COLADA- benzocaine gel
SMARTPRACTICE TOPICAL ANESTHETIC GEL BUBBLE GUM- benzocaine gel
SMARTPRACTICE TOPICAL ANESTHETIC GEL STRAWBERRY- benzocaine gel
SMARTPRACTICE TOPICAL ANESTHETIC GEL CHERRY- benzocaine gel
SMARTPRACTICE TOPICAL ANESTHETIC GEL MINT- benzocaine gel
SMARTPRACTICE TOPICAL ANESTHETIC GEL RASPBERRY- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69521-011-34, 69521-021-34, 69521-031-34, 69521-041-34, view more69521-051-34, 69521-061-34 - Packager: SmartHealth, Inc. (DBA SmartPractice)
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 28, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DESCRIPTION
- INDICATIONS
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
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DOSAGE AND ADMINISTRATION
1. Each gram of benzocaine gel between 180-220mg benzocaine in a flavored base.
2. Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle.
3. For topical tissue anesthesia during scaling procedures, dispense a small amount of gel into a dappen dish, then coat the scaler with the product prior to use.
4. Tightly re-cap the jar after each use.
- STORAGE
- DISTRIBUTED BY
- PRINCIPAL DISPLAY PANEL - Cherry
- PRICIPAL DISPLAY PANEL - Mint
- PRINCIPAL DISPLAY PANEL - Pina Colada
- PRINCIPAL DISPL;AY PANEL - Bubble Gum
- PRINCIPAL DISPLAY PANEL - Strawberry
- PRINCIPAL DISPLAY PANEL - Raspberry
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INGREDIENTS AND APPEARANCE
SMARTPRACTICE TOPICAL ANESTHETIC GEL PINA COLADA
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69521-041 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) Product Characteristics Color Score Shape Size Flavor COCONUT (Pina Colada) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69521-041-34 34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/19/1963 SMARTPRACTICE TOPICAL ANESTHETIC GEL BUBBLE GUM
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69521-031 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) D&C RED NO. 28 (UNII: 767IP0Y5NH) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 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:69521-031-34 34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/19/1963 SMARTPRACTICE TOPICAL ANESTHETIC GEL STRAWBERRY
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69521-051 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 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:69521-051-34 34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/19/1963 SMARTPRACTICE TOPICAL ANESTHETIC GEL CHERRY
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69521-021 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 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:69521-021-34 34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/19/1963 SMARTPRACTICE TOPICAL ANESTHETIC GEL MINT
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69521-011 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 PEPPERMINT OIL (UNII: AV092KU4JH) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 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:69521-011-34 34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/19/1963 SMARTPRACTICE TOPICAL ANESTHETIC GEL RASPBERRY
benzocaine gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69521-061 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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:69521-061-34 34 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/19/1963 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/19/1963 Labeler - SmartHealth, Inc. (DBA SmartPractice) (061081477) Establishment Name Address ID/FEI Business Operations Dentsply Caulk 083235549 manufacture(69521-041, 69521-011, 69521-021, 69521-031, 69521-051, 69521-061)
