CHLORAPREP

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:19:20

Label at a glance#

ProductCHLORAPREP
Active ingredientISOPROPYL ALCOHOL, CHLORHEXIDINE GLUCONATE
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate (CHG), 2% w/v

and Isopropyl alcohol (IPA), 70% v/v

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame.

do not use with electrocautery procedures

Allegery Alert

SPL UNCLASSIFIED 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.

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

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. 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.

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
maximal treatment area for one applicator
one single swabstick applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)
tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area.
completely wet the treatment area with antiseptic
dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds. (When using the triple swabstick applicators, use each swabstick sequentially within the 30 seconds). Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away.
moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes. (When using the triple swabstick applicators, use each swabstick sequentially within the 2 minutes). Allow the area to air dry for approximately 1 minute. Do not blot or wipe away.
discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

INACTIVE INGREDIENT SECTION

USP purified water

OTHER SAFETY INFORMATION

store between 15-30 ºC (59-86 °F)
avoid freezing and excessive heat above 40 ºC (104 °F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00351662167519(17)500101(21)279392414059(10)HF1234TESTINGGTIN-14: 00351662167519
GTIN-12: 351662167519
UPC-A: 351662167519
EAN-13: 0351662167519
GTIN storage (14 digits): 00351662167519
51662-1675-1 .jpg

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
51662-1675-1CHLORAPREP1.75 mL in 1 APPLICATORSOLUTION1.751
51662-1675-1CHLORAPREP1 in 1 POUCHSOLUTION11

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51662-167551662-1675-1
54365-401

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
N021555-001CHLORAPREP ONE-STEP SEPPCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07
N021555-002CHLORAPREP SINGLE SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10
N021555-003CHLORAPREP TRIPLE SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10

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 22:38:342026-08N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-0784e616aacf4f…
2026-09-14 22:38:342026-08N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-1084e616aacf4f…
2026-09-14 22:38:342026-08N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-1084e616aacf4f…
2026-08-18 06:07:402026-07N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021555-002CHLORAPREP SINGLE SWABSTICK2%;70% (1.75ML)SWAB / TOPICALRLD, RS2005-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021555-003CHLORAPREP TRIPLE SWABSTICK2%;70% (5.25ML)SWAB / TOPICALRLD, RS2009-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021555-001CHLORAPREP ONE-STEP SEPP2%;70% (0.67ML)SWAB / TOPICALRLD, RS2002-10-07301d65b070ca…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORAPREPCHLORAPREPHF Acquisition Co LLC, DBA HealthFirst44fe08e0-4e9c-8bd6-e063-6394a90a0e2b2025-12-02WarningsExact identifier
ndc (package): 51662-1675-1
ndc (product): 51662-1675
ndc11 (package): 51662167501
spl id: 44fe08e0-4e9d-8bd6-e063-6394a90a0e2b
spl set id: 44fe08e0-4e9c-8bd6-e063-6394a90a0e2b
ChloraPrep SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213 LLC1666069b-38f6-bfde-e063-6394a90ad1b82025-10-17WarningsExact identifier
ndc (product): 54365-401

Reported adverse events (FAERS/openFDA)#

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