FDA.reportPublic FDA data

A4254 NERVE BLOCK

Manufacturer
Smiths Medical ASD, Inc. | Aplicare, Inc.
Effective date
2016-10-24
Label type
MEDICAL DEVICE
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:22:08

Label at a glance#

ProductA4254 NERVE BLOCK
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine

OTC - PURPOSE SECTION

Antiseptic

Antiseptic skin preparation

WARNINGS SECTION

Do not use

-if allergic to iodine

-in the eyes

For external use only

Ask a doctor before use if injuries are

-deep or puncture wounds

-serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

-redness, irritation, swelling or pain persists or increases

-infection occurs

Avoid pooling beneath patient

Avoid excessive heat. Store at room temperature.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

INSTRUCTIONS FOR USE SECTION

Apply locally as needed.

OTHER SAFETY INFORMATION

  • 1% titratable iodine
  • latex free
  • for hospital or professional use only

INACTIVE INGREDIENT SECTION

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

OTC - QUESTIONS SECTION

1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APLICARE

POVIDONE-IODINE SOLUTION

ANTISEPTIC

STERILE Solution

Povidone Iodine SolutionPovidone Iodine Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

A4254A4254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0001-1ML - Milliliter52380-0001edd25a2a-aabd-433e-b5a8-ef9471c1b24412012-07-24
52380-0001-3ML - Milliliter52380-00019f05eb45-3f8e-4fd9-814a-476eb917bf5c12021-11-09
52380-0001-5EA - Each52380-00019755da7f-19a8-4706-8c70-17752ffe417512012-07-24

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
51688-654851688-6548-2
52380-000152380-0001-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM HYDROXIDE55X04QC32IIACT
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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 9 · 165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINEHenry Schein, Inc.313416b8-60b2-4a77-9b56-5c507aae90722026-09-08WarningsName fallback
generic name: POVIDONE-IODINE
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC7302a2f8-a600-4200-bc4e-309e4c190fe52026-09-02WarningsName fallback
generic name: POVIDONE-IODINE
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCb8a23a29-2541-4987-a534-17a6369a6c8d2026-09-02WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-Iodine Topical AntisepticPOVIDONE-IODINEMedline Industries, LPc9036a83-22f5-4a09-b01c-7093d4192c192026-08-28WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINEMajor Pharmaceuticals59041ca3-a195-5a20-e063-6394a90a2ac92026-08-14WarningsName fallback
generic name: POVIDONE-IODINE
Lights Povidone Iodine SwabsticksPOVIDONE-IODINELights Medical Manufacture Co., Ltd.664bbf9f-650a-45fd-b9b8-d93f0ba631902026-07-22WarningsName fallback
generic name: POVIDONE-IODINE
McKesson PVP Prep SolutionPOVIDONE-IODINEMcKesson Medical-Surgical33fa233c-b43c-42d8-af37-a58f098a0d512026-07-21WarningsName fallback
generic name: POVIDONE-IODINE
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCff19ea2f-d6a0-442f-8f23-d559fc13c5492026-07-14WarningsName fallback
generic name: POVIDONE-IODINE
MedlinePOVIDONE-IODINEMedline Industries, LP1d731a44-f16e-c249-e063-6294a90a39b82026-07-08WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINECARDINAL HEALTH 110, LLC. DBA LEADER4f0d8da5-a75b-acc7-e063-6394a90ae8392026-07-08WarningsName fallback
generic name: POVIDONE-IODINE
PVP-I Prep PadPOVIDONE-IODINEProfessional Disposables International, Inc.57b02fbb-a9a6-0b8c-e063-6394a90a44f32026-06-22WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-Iodine Scrub SolutionPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdefa7f9f6-ae02-4104-bb9e-16e1ffd2be7a2026-06-17WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINEH E B4a7a627c-505d-992b-e063-6394a90a54ca2026-06-04Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
Povidone IodinePOVIDONE-IODINEAmerisource Bergenf69a5cec-04f2-4028-94c6-1f129d2de5a92026-06-04WarningsName fallback
generic name: POVIDONE-IODINE
Maokang Povidone-Iodine Paint Solution AntisepticPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd48f81109-3791-46ef-8992-d53b677a51b62026-06-02WarningsName fallback
generic name: POVIDONE-IODINE
Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)POVIDONE-IODINEXINXIANG XINDA TECHNOLOGY CO.,LTD51c29301-978a-0d46-e063-6394a90ab9e42026-05-14WarningsName fallback
generic name: POVIDONE-IODINE
Lightning X Iodine Prep PadsPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd.5136a99b-ef40-937e-e063-6394a90a0a952026-05-07WarningsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINERetail Business Services, LLCad4e49b6-5784-4880-950b-6e6175fc312b2026-04-30Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
3M Skin and Nasal AntisepticPOVIDONE-IODINESolventum US LLC1a94494d-7dd3-4f32-bc42-81c199fe233e2026-04-22WarningsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINEAmazon.com Services LLC3e2b255c-e3b7-468c-9ac1-b63279c5ac7f2026-03-20Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE

Reported adverse events (FAERS/openFDA)#

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