Roman Swipes

Approved

Approval ID

7f0eac8c-7235-99d8-e053-2a91aa0a634e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Feb 12, 2025

Manufacturers

FDA

Roman Health Ventures Inc.

DUNS: 081317350

Products 1

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

NDC Product Code72484-433

Application NumberM017

Marketing CategoryC200263

Route of AdministrationTOPICAL

Effective DateFebruary 12, 2025

Generic NameBenzocaine

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

BENZOCAINEActive

Quantity: 4 g in 100 mL

Code: U3RSY48JW5

Classification: ACTIB