A4077 NERVE BLOCK

Manufacturer
Smiths Medical ASD, Inc. | CareFusion 213 LLC
Effective date
2013-06-13
Label type
MEDICAL DEVICE
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:40:34

Label at a glance#

ProductA4077 NERVE BLOCK
Active ingredientCHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL
Label structure14 sections

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 guluconate 2% w/v

Isopropyl alchohol 70% v/v

OTC - PURPOSE SECTION

Purposes

Antiseptic

Use

for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria 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
  • 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

OTC - DO NOT USE SECTION

            Do not use

  • 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

OTC - WHEN USING SECTION

           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.

OTC - STOP USE SECTION

           Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

INSTRUCTIONS FOR USE SECTION

           Directions

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • use in a well ventilated area
  • maximal treatment area for one applicator is approximately 4 in. x 5 in. (130 cm2)
  • remove applicator from package;do not touch sponge
  • hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic.
  • wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
  • completely wet the treatment area with antiseptic
  • dry surgical sites (e.g., abdomen or arm):use gentle repeated back-and-forth strokes for 30 seconds
  • moist surgical sites (e.g., inguinal fold):use gentle repeated back-and-forth strokes for 2 minutes
  • 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 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.

OTHER SAFETY INFORMATION

           Other information

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)
  • the tint will slowly fade from the skin. Soap and water, or alcohol may be used to remove the tint if desired.

INACTIVE INGREDIENT SECTION

            Inactive ingredients

  • FD C yellow #6 dye
  • USP purified water

OTC - QUESTIONS SECTION

            Questions?

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

Chloraprep Solution
Chloraprep Solution

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

A4077A4077

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)20351688080704GTIN-14: 20351688080704
GTIN storage (14 digits): 20351688080704
A4077.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8E1
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163021
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52L1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163021
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51688-640351688-6403-2
54365-40054365-400-11

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 · 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.