FDA.reportPublic FDA data

Splinter First Aid Kit

Manufacturer
Honeywell Safety Products USA, Inc | Sion Biotext Medical
Effective date
2018-08-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:56:39

Label at a glance#

ProductSplinter First Aid Kit
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Indications and uses

first aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Dosage and administration

clean the affected area apply1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone iodine 10% (equivalent to 1% titrateable iodine)

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

  • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or persists for more than 72 hours
  • irritation and redness develops

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

  • clean the affected area
  • apply1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

OTHER SAFETY INFORMATION

  • do not use on individuals who are allergic or sensitive to iodine
  • store at controlled temperature 59-86ºF (15-30ºC)
  • do not use if pouch is open or torn
  • discard after each use

Inactive ingredients

INACTIVE INGREDIENT SECTION

nonoxynol 9, water

Questions

OTC - QUESTIONS SECTION

1-800-430-5490

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiseptic Wipe PVPAntiseptic Wipe PVP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037205povidone-iodine 1 % Medicated PadPSN4
1037205povidone-iodine 10 MG/ML Medicated PadSCD4
1037205povidone-iodine 1 % Medicated PadSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0498-9002-002020-01-31C16284748780-19d75b9d0-6244-f424-e053-dadaa90a57ceSplint First Aid Kit: 02-10-70X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0498-9002-00Splinter First Aid Kit1 in 1 KITKIT14
0498-9002-00Splinter First Aid Kit1 in 1 POUCHKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-0120SPLINTER FIRST AID KIT (POVIDONE IODINE,) KIT [HONEYWELL SAFETY PRODUCTS USA, INC]4Unmatched20180823_61944af7-1304-c847-e053-2a91aa0ab8f6.zip
0498-9002SPLINTER FIRST AID KIT (POVIDONE IODINE,) KIT [HONEYWELL SAFETY PRODUCTS USA, INC]4Legacy NDC, 2 package rows20180823_61944af7-1304-c847-e053-2a91aa0ab8f6.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0498-90020498-9002-00
0498-01200498-0120-00

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
NONOXYNOL-948Q180SH9TIACT
POVIDONE-IODINE85H0HZU99MACTIM
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
74197d46-dfe0-87fb-e053-2991aa0a34fd61944af7-1304-c847-e053-2a91aa0ab8f62018-08-23WarningsExact identifier
spl id: 74197d46-dfe0-87fb-e053-2991aa0a34fd
spl set id: 61944af7-1304-c847-e053-2a91aa0ab8f6

Reported adverse events (FAERS/openFDA)#

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