Prevantics Swab

Manufacturer: Professional Disposables International, Inc.
Effective date: 2023-10-13
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-05-31 23:56:46

Label at a glance#

ProductPrevantics Swab

Active ingredientCHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL

Label structure8 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 swab is approximately 2.5 by 2.5 inches (6 by 6 cm) tear open packet and remove swab. Do not unfold swab. prior to injection, apply swab to the procedure site by holding swab between thumb and index finger. Apply swab to skin using repeated back-and-forth stroke...

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

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 an injection

Warnings

WARNINGS SECTION

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

Allergy alert

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 ingredient 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 swab is approximately 2.5 by 2.5 inches (6 by 6 cm)
tear open packet and remove swab. Do not unfold swab.
prior to injection, apply swab to the procedure site by holding swab between thumb and index finger. Apply swab to skin using repeated back-and-forth strokes for 15 seconds.
allow the prepped area to air dry for 30 seconds
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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packet Label

packet

Box Label box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1191171	chlorhexidine gluconate 3.15 % / Isopropyl Alcohol 70 % Medicated Pad	PSN	10
1366736	Prevantics 3.15 % / 70 % Swabstick	PSN	10
1366736	chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad [Prevantics]	SBD	10
1191171	chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	10
1366736	Prevantics (chlorhexidine gluconate 3.15 % / isopropyl alcohol 70 % ) Swabstick	SY	10
1366736	Prevantics (chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML) Medicated Pad	SY	10

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHLORHEXIDINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10819-1080-1	Prevantics Swab	100 in 1 BOX	SOLUTION	100		10
10819-1080-1	Prevantics Swab	1 mL in 1 POUCH	SOLUTION	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10819-1080	PREVANTICS SWAB (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20231014_db61e7fd-c421-4e3c-bc88-0343230273de.zip

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 Swab
Chlorhexidine Gluconate and Isopropyl Alcohol
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE
WATER
ISOPROPYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10819-1080	10819-1080-1

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
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB
WATER	059QF0KO0R	IACT
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 43.

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021524-002	PREVANTICS SWABSTICK	3.15%;70% (1.6ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021524-003	PREVANTICS MAXI SWABSTICK	3.15%;70% (5.1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021524-001	PREVANTICS SWAB	3.15%;70% (1ML)	SWAB / TOPICAL	RLD, RS	2005-06-03	`301d65b070ca…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prevantics Swab	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	Professional Disposables International, Inc.	ff999b50-0b6b-404e-b4f1-c6694fe47a9b	2023-10-13	Warnings	Exact identifier ndc (product): 10819-1080
Prevantics Swab	CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL	Professional Disposables International, Inc.	db61e7fd-c421-4e3c-bc88-0343230273de	2023-10-13	Warnings	Exact identifier ndc (package): 10819-1080-1 ndc (product): 10819-1080 ndc11 (package): 10819108001 spl id: 079d6f47-65e3-2f14-e063-6394a90a444a spl set id: db61e7fd-c421-4e3c-bc88-0343230273de

Reported adverse events (FAERS/openFDA)#

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