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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69521-021
Product Classification
G
Generic Name
benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69521-051
Product Classification
G
Generic Name
benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69521-031
Product Classification
G
Generic Name
benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69521-011
Product Classification
G
Generic Name
benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69521-061
Product Classification
G
Generic Name
benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69521-041
Product Classification
G
Generic Name
benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateDecember 28, 2017
FDA Product Classification

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.

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SmartPractice topical anesthetic gel - FDA Drug Approval Details