DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5%

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 080105003

Effective Date

May 10, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Phenylephrine(1 g in 100 g)

Cinchocaine(0.5 g in 100 g)

Lidocaine(15 g in 100 g)

Prilocaine(5 g in 100 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Sincerus Florida, LLC

DUNS Number

080105003

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

NDC Product Code

72934-5071

Route of Administration

TOPICAL

Effective Date

May 10, 2019

Ingredients

Code: 04JA59TNSJClass: ACTIBQuantity: 1 g in 100 g

Code: Z97702A5DGClass: ACTIBQuantity: 0.5 g in 100 g

Code: 98PI200987Class: ACTIBQuantity: 15 g in 100 g

Code: 046O35D44RClass: ACTIBQuantity: 5 g in 100 g