PORTEX NERVE BLOCK

Manufacturer
Smiths Medical ASD, Inc. | CareFusion 213 LLC
Effective date
2011-06-03
Label type
MEDICAL DEVICE
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:51:17

Label at a glance#

ProductPORTEX NERVE BLOCK A3632
Active ingredientCHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL
Label structure9 sections

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION SECTION

CHLORAPREP ONE-STEP (chlorhexidine gluconate and isopropyl aclohol) solution
[CareFusion 213 LLC]


OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

OTC - PURPOSE SECTION

Purposes

Antiseptic

Antiseptic

Use

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

WARNINGS SECTION

Warnings

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
  • 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).
  • avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
  • do not allow solution to pool
  • remove wet materials from prep area
Do not use
  • in children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption
  • on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
  • for lumbar puncture or in contact with the meninges
  • on open skin wounds or as a general skin cleanser
When using this product
  • 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.
Stop use and ask a doctor if
  • irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Keep out of reach of children.

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

INDICATIONS & USAGE SECTION

Directions
  • to reduce the risk of fire the following strategies are recommended:
    • use in a well ventilated area
    • avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
    • do not allow solution to pool
    • tuck prep towels to absorb solution, and then remove
    • remove wet material from prep area
  • maximal treatment area for one applicator is approximately 4 in. x 5 in. (130 cm2). Discard the applicator after a single use.
  • pinch the wings on the applicator to break the ampule and release the antiseptic. Do not touch the sponge. Wet the sponge by repeatedly pressing and releasing the sponge against the treatment area until liquid is visible on the skin.
  • dry surgical sites (such as abdomen or arm): Use repeated back-and-forth strokes of the sponge for approximately 30 seconds. Completely wet the treatment area with antiseptic. Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away.
  • moist surgical sites (such as the inguinal fold): Use repeated back-and-forth strokes of the sponge for approximately 2 minutes. Completely wet the treatment area with antiseptic. Allow the area to air dry for approximately one (1) minute. Do not blot or wipe away.

STORAGE AND HANDLING SECTION

Other information
  • store between 15-30 °C (59-86 °F)
  • avoid freezing and excessive heat above 40 °C (104 °F)

OTC - QUESTIONS SECTION

Questions?

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 054365-400-11

3ml APPLICATORS

Hi-Lite Orange®

Single Use

Latex Free

Applicator is STERILE if package is intact

Store between 15-30 °C (59-86 °F)

Avoid freezing and excessive heat above 40 °C (104 °F)

25 applicators

0.10 fl. oz. (3 ml) each

ChloraPrep® With Tint

2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol

Patient Preoperative Skin Preparation

WARNING FLAMMABLE

Keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

  • solution contains alcohol and gives off flammable vapors
  • 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).
  • avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
  • do not allow solution to pool
  • remove wet material from prep area
ChloraPrep Applicator
ChloraPrep Applicator


A3632 PORTEX NERVE BLOCK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

A3632 PORTEX NERVE BLOCK

Tyvek LidTyvek Lid

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8E2
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163022
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52L2
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163022
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51688-602551688-6025-2
54365-40054365-400-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / RECTAL0.5 %w/vExact identifier — unii+dosage form
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+dosage form
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LOTION / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOAP / TOPICAL0.2 %w/wExact identifier — unii+route
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SPONGE / TOPICAL0.01 %w/wExact identifier — unii+route
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+dosage form
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOAP / TOPICAL0.2 %w/wExact identifier — unii+route
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LOTION / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / RECTAL0.5 %w/vExact identifier — unii+dosage form
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SPONGE / TOPICAL0.01 %w/wExact identifier — unii+route
12 equally ranked IID candidates

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85291b2b-40b9-07fa-e053-2a91aa0a84e42025-11-04WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85416361-90b5-3efa-e053-2a91aa0af4312025-11-03WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8528a4f5-5ff4-45f3-e053-2991aa0a804c2025-11-03WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8529596f-37e4-c44e-e053-2a91aa0ad0142025-10-30WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8578da30-a155-2505-e053-2991aa0a2c042025-10-29WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8541f219-c060-399a-e053-2991aa0ab05c2025-10-24WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8541a1ed-2a92-1fab-e053-2a91aa0a29d12025-10-23WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85790749-5a95-7f18-e053-2a91aa0a1a022025-10-17WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85791e13-4103-19fe-e053-2991aa0a647f2025-10-17WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85794f6b-d1ea-40f9-e053-2991aa0a88232025-10-17WarningsExact identifier
ndc (product): 54365-400
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213 LLCf06e4f9d-6cef-b57a-e053-2a95a90a73372025-07-03WarningsExact identifier
ndc (product): 54365-400

Reported adverse events (FAERS/openFDA)#

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