Prevantics Swab, Prevantics Swabstick, Prevantics Maxi Swabstick

NDA 21524, held by Prof Dspls. Chlorhexidine Gluconate; Isopropyl Alcohol.

As of Nov 14, 2026, NDA 21524 (Prevantics Swab, Prevantics Swabstick, Prevantics Maxi Swabstick), held by Prof Dspls, was first approved by FDA on Jun 3, 2005, with 11 approved supplements and 0 published complete response letters.

First approved: Jun 3, 2005
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use for the preparation of the patient's skin prior to surgery or injection

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Feb 14, 2018	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter
Jun 3, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Prevantics Swab3.15%;70% (1ML) · swab;topical	Chlorhexidine Gluconate; Isopropyl Alcohol	OTCReference drug
Prevantics Swabstick3.15%;70% (1.6ML) · swab;topical	Chlorhexidine Gluconate; Isopropyl Alcohol	OTCReference drug
Prevantics Maxi Swabstick3.15%;70% (5.1ML) · swab;topical	Chlorhexidine Gluconate; Isopropyl Alcohol	OTCReference drug

All 12 submissions, including labeling and manufacturing supplements


Sep 20, 2021	Supplement 24Labeling · Standard review	Approved	Label Letter
Jan 16, 2019	Supplement 20Labeling · Standard review	Approved	Label Letter
Feb 14, 2018	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter
Sep 7, 2017	Supplement 17Labeling · Standard review	Approved	Letter Label
Jul 25, 2014	Supplement 15Labeling · Standard review	Approved	Label Letter
Mar 24, 2014	Supplement 14Labeling · Standard review	Approved	Letter Label
May 17, 2012	Supplement 11Labeling · Standard review	Approved	Letter
Mar 1, 2012	Supplement 10Labeling · Standard review	Approved	Letter
Aug 13, 2009	Supplement 8Manufacturing	Approved	None posted
Oct 15, 2007	Supplement 4Manufacturing · Standard review	Approved	Letter Label
Mar 20, 2007	Supplement 3Manufacturing	Approved	Letter Label
Jun 3, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21524
Drugs@FDA: Overview at FDA
Company: Prof DSPLS

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters