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ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL

Approved
Approval ID

f03315ac-b685-4e7d-aacb-45f8bbf9bb70

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 16, 2011

Manufacturers
FDA

HAGER WORLDWIDE, INC.

DUNS: 009277971

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62565-901
Product Classification
G
Generic Name
BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationTOPICAL, DENTAL
Effective DateNovember 16, 2011
FDA Product Classification

INGREDIENTS (4)

BENZOCAINEActive
Quantity: 28 mg in .2 g
Code: U3RSY48JW5
Classification: ACTIB
TETRACAINE HYDROCHLORIDEActive
Quantity: 4 mg in .2 g
Code: 5NF5D4OPCI
Classification: ACTIB
BUTAMBENActive
Quantity: 4 mg in .2 g
Code: EFW857872Q
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 1 mg in .2 g
Code: F5UM2KM3W7
Classification: IACT

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ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL - FDA Drug Approval Details