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FDA Approval

ONEXTON

CompanyBausch Health US, LLC (DUNS: 831922468)

Effective Date

April 6, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Clindamycin(10 mg in 1 g)

Benzoyl peroxide(37.5 mg in 1 g)

Manufacturing Establishments (2)

Contract Pharmaceuticals Limited Canada

Labeler

Bausch Health US, LLC

DUNS Number

248761249

Bausch Health Companies, Inc.

Labeler

Bausch Health US, LLC

DUNS Number

245141858

Products (1)

ONEXTON

NDC Product Code

0187-3050

Application Number

NDA050819

Marketing Category

NDA (C73594)

Route of Administration

TOPICAL

Effective Date

April 6, 2020

Ingredients

ClindamycinActive

Code: EH6D7113I8Class: ACTIMQuantity: 10 mg in 1 g

WaterInactive

Code: 059QF0KO0RClass: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

potassium hydroxideInactive

Code: WZH3C48M4TClass: IACT

Benzoyl peroxideActive

Code: W9WZN9A0GMClass: ACTIBQuantity: 37.5 mg in 1 g

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive

Code: 4Q93RCW27EClass: IACT

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