SmartPractice topical anesthetic gel
SmartPractice topical anesthetic gel
Approved
Approval ID
616aa460-7857-9f4d-e053-2a91aa0a5d58
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2017
Manufacturers
FDA
SmartHealth, Inc. (DBA SmartPractice)
DUNS: 061081477
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
benzocaine
PRODUCT DETAILS
NDC Product Code69521-021
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
Generic Namebenzocaine
INGREDIENTS (6)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
BENZOCAINEActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
benzocaine
PRODUCT DETAILS
NDC Product Code69521-051
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
Generic Namebenzocaine
INGREDIENTS (6)
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZOCAINEActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
benzocaine
PRODUCT DETAILS
NDC Product Code69521-031
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
Generic Namebenzocaine
INGREDIENTS (6)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
BENZOCAINEActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
benzocaine
PRODUCT DETAILS
NDC Product Code69521-011
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
Generic Namebenzocaine
INGREDIENTS (7)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
D&C GREEN NO. 5Inactive
Code: 8J6RDU8L9X
Classification: IACT
BENZOCAINEActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
benzocaine
PRODUCT DETAILS
NDC Product Code69521-061
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
Generic Namebenzocaine
INGREDIENTS (8)
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
BENZOCAINEActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
benzocaine
PRODUCT DETAILS
NDC Product Code69521-041
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
Generic Namebenzocaine
INGREDIENTS (4)
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
BENZOCAINEActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Drug Labeling Information
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 10/14/2008
CONTRAINDICATIONS
Should not be used with individuals with a known sensitivity to benzocaine or PABA.
DESCRIPTION SECTION
LOINC: 34089-3Updated: 10/14/2008
DESCRIPTION
Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.
WARNINGS SECTION
LOINC: 34071-1Updated: 10/14/2008
WARNINGS
Keep out of reach of children. For professional dental use only.
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 10/14/2008
STORAGE
Store between 59°-86°F (15°-30°C). Protect from freezing.
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 10/14/2008
DISTRIBUTED BY
distributed by:
SmartPractice
3400 east mcdowell rd
phoenix, AZ 85008
Made in USA.