Prevantics swabstick

Manufacturer: Professional Disposables International, Inc.
Effective date: 2019-10-31
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 23:49:26

Label at a glance#

ProductPrevantics swabstick

Active ingredientCHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL

Label structure9 sections

Dosage and administration

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. maximum treatment area for one swabstick is approximately: dry site: 4 by 4 inches (10 by 10 cm) or moist site: 3 by 5 inches (7.5 by 12.5 cm) peal apart the pouch to expose the swabstick remove the swabstick from package. Do not touch the foam tip. prior to surgery or injection, apply one fl...

Storage and handling

store between 68-77°F (20-25°C) avoid freezing and excessive heat above 104°F (40°C) for hospital and professional use only

Contacts and useful links#

PhoneLabel contact1-800-999-6423

Websitewww.pdipdi.com

www.pdipdi.com

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 3.15% w/v

Isopropyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only
Flammable, keep away from fire or flame
Do not use with electrocautery procedures

Allergy alert:

USER SAFETY WARNINGS SECTION

This product may cause a severe allergic reaction. Symptoms may include:

wheezing/difficulty breathing
shock
facial swelling
hives
rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

on patients allergic to chlorhexidine gluconate or any other ingredients in this product
for lumbar puncture or in contact with the meninges
on open skin wounds or as a general skin cleanser
under occlusive patch

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, mouth and mucous membranes. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

_________________________________________________________________

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
maximum treatment area for one swabstick is approximately: dry site: 4 by 4 inches (10 by 10 cm) or moist site: 3 by 5 inches (7.5 by 12.5 cm)
peal apart the pouch to expose the swabstick
remove the swabstick from package. Do not touch the foam tip.
prior to surgery or injection, apply one flat side of foam tip to the proposed skin site and prep the skin in vigorous back-and-forth repeated strokes, turning the swabstick over (unused side of the foam tip) halfway in the procedure.
dry site: scrub repeatedly back and forth for 15 seconds with each side of the applicator for a total of 30 seconds. Allow to air dry for approximately 30 seconds.
moist site: scrub repeatedly back and forth for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 1.5 minutes.
do not blot or wipe dry
discard after a single use

Other information

STORAGE AND HANDLING SECTION

store between 68-77°F (20-25°C)
avoid freezing and excessive heat above 104°F (40°C)
for hospital and professional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

USP purified water

Questions?

OTC - QUESTIONS SECTION

call 1-800-999-6423, M-F (9:00 am-5:00 pm EST)

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Reorder No. S40750
NDC 10819-4075-1

Prevantics(R) Swabstick

[Chlorhexidine Gluconate (3.15%)* and Isopropyl Alcohol (70%) Swab]

Patient preoperative skin preparation

Non-sterile Solution

*equivalent to 50mg of Chlorhexidine Gluconate per pouch

For external use only

Single step, broad spectrum, persistent antiseptic that significantly reduces the number of microorganisms on intact skin
Use for the preparation of the patient's skin prior to surgery or injection
Helps reduce bacteria that potentially can cause skin infection
Latex free
For hospital and professional use only

IMPORTANT: See carton for complete Drug Facts and safety information.

Professional Disposables International, Inc.
Orangeburg, NY 10962-1376
USA - 1-800-999-6423
www.pdipdi.com

One Swabstick, 0.054 fl. oz. (1.6 mL) Each

Packet Label: packet swabstick

Box Label bx swabstick

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHLORHEXIDINE GLUCONATE	ACTIVE INGREDIENT	MOR84MUD8E	5
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	5
CHLORHEXIDINE	ACTIVE MOIETY	R4KO0DY52L	5
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Prevantics swabstick
chlorhexidine gluconate and isopropyl alcohol
WATER
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE
ISOPROPYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10819-4075	10819-4075-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB
ISOPROPYL ALCOHOL	ND2M416302	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021524-001	PREVANTICS SWAB	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03
N021524-002	PREVANTICS SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03
N021524-003	PREVANTICS MAXI SWABSTICK	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`79d66fd596c7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021524-001	M-221	2021-02-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021524-002	M-221	2021-02-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021524-003	M-221	2021-02-14	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021524-001	M-221	2021-02-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021524-002	M-221	2021-02-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021524-003	M-221	2021-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021524-001	M-221	2021-02-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021524-002	M-221	2021-02-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021524-003	M-221	2021-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021524-001	M-221	2021-02-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021524-002	M-221	2021-02-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021524-003	M-221	2021-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021524-001	M-221	2021-02-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021524-002	M-221	2021-02-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021524-003	M-221	2021-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021524-001	M-221	2021-02-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021524-002	M-221	2021-02-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021524-003	M-221	2021-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021524-001	M-221	2021-02-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021524-002	M-221	2021-02-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021524-003	M-221	2021-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021524-001	M-221	2021-02-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021524-002	M-221	2021-02-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021524-003	M-221	2021-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021524-001	M-221	2021-02-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021524-002	M-221	2021-02-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021524-003	M-221	2021-02-14	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
963745b8-73a8-488e-e053-2995a90a55d6			2de6aca2-5538-49a4-be9e-abc05c4d7de9	2019-10-31	Warnings	Exact identifier spl id: 963745b8-73a8-488e-e053-2995a90a55d6 spl set id: 2de6aca2-5538-49a4-be9e-abc05c4d7de9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.