Prevantics Maxi Swabstick

Manufacturer
Professional Disposables International, Inc.
Effective date
2023-06-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:55:27

Label at a glance#

ProductPrevantics Maxi Swabstick
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 swabstick is approximately 8.4 in. x 8.4 in. (21.3 cm by 21.3 cm). tear open the pouch to expose the swabstick remove 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 ...

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

Purposes

OTC - PURPOSE SECTION

Antiseptic

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

To reduce the risk of fire, PREP CAREFULLY:

  • solution contains alcohol and gives off flammable vapors
  • avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
  • do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
  • do not allow solution to pool
  • remove wet materials from prep area

​​​

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 swabstick is approximately 8.4 in. x 8.4 in. (21.3 cm by 21.3 cm).
  • tear open the pouch to expose the swabstick
  • remove 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 for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 1.5 minutes.
  • if using an ignition source, allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair).
  • do not blot or wipe away
  • 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

Prevantics(R) Maxi Swabstick
[Chlorhexidine Gluconate (3.15%)*
and Isopropyl Alcohol (70%) Swab]

Patient preoperative skin preparation
Non-sterile solution

Packaging is sterile when in sterile kit

*equivalent to 161 mg of Chlorhexidine Gluconate per pouch

  • For External Use Only
  • Use for the preparation of the patient's skin prior to surgery or injection
  • Helps reduce bacteria that potentially can cause skin infection
  • For hospital and professional use only
  • Latex free

IMPORTANT: See carton for complete Drug Factsand safety information.

Packet Label

packet 1packet 1

Box Label

box 1box 1

Packet (bulk):

Packet 2Packet 2

Insert:

Product InsertProduct Insert

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1191171chlorhexidine gluconate 3.15 % / Isopropyl Alcohol 70 % Medicated PadPSN4
1366736Prevantics 3.15 % / 70 % SwabstickPSN4
1366736chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad [Prevantics]SBD4
1191171chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated PadSCD4
1366736Prevantics (chlorhexidine gluconate 3.15 % / isopropyl alcohol 70 % ) SwabstickSY4
1366736Prevantics (chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML) Medicated PadSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10819-4076-3Prevantics Maxi Swabstick300 in 1 CASESOLUTION3004
10819-4076-3Prevantics Maxi Swabstick5.1 mL in 1 POUCHSOLUTION5.14
10819-4076-4Prevantics Maxi Swabstick30 in 1 BOXSOLUTION304
10819-4076-4Prevantics Maxi Swabstick5.1 mL in 1 POUCHSOLUTION5.14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10819-4076PREVANTICS MAXI SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]4Current NDC, Legacy NDC, 4 package rows20230701_93ca3c07-40b4-3a91-e053-2995a90a0afd.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10819-407610819-4076-4, 10819-4076-3

Ingredients#

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

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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021524-001PREVANTICS SWABCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03
N021524-002PREVANTICS SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03
N021524-003PREVANTICS MAXI SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-0384e616aacf4f…
2026-08-18 06:07:402026-07N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03301d65b070ca…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021524-001M-2212021-02-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021524-002M-2212021-02-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021524-003M-2212021-02-1474a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021524-001M-2212021-02-14782e0a99824c…
2021-12-28 21:50 UTC2021-12N021524-002M-2212021-02-14782e0a99824c…
2021-12-28 21:50 UTC2021-12N021524-003M-2212021-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021524-001M-2212021-02-1487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021524-002M-2212021-02-1487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021524-003M-2212021-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N021524-001M-2212021-02-145aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021524-002M-2212021-02-145aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021524-003M-2212021-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021524-001M-2212021-02-148869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021524-002M-2212021-02-148869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021524-003M-2212021-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021524-001M-2212021-02-14c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021524-002M-2212021-02-14c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021524-003M-2212021-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021524-001M-2212021-02-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021524-002M-2212021-02-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021524-003M-2212021-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09N021524-001M-2212021-02-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N021524-002M-2212021-02-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N021524-003M-2212021-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N021524-001M-2212021-02-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N021524-002M-2212021-02-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N021524-003M-2212021-02-14ea99ee380514…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prevantics Maxi SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.93ca3c07-40b4-3a91-e053-2995a90a0afd2023-06-30WarningsExact identifier
ndc (package): 10819-4076-3
ndc (package): 10819-4076-4
ndc (product): 10819-4076
ndc11 (package): 10819407604
ndc11 (package): 10819407603
spl id: f5aff4be-ddc9-63ad-e053-2a95a90a426b
spl set id: 93ca3c07-40b4-3a91-e053-2995a90a0afd

Reported adverse events (FAERS/openFDA)#

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