SPLINTER FIRST AID KIT- povidone iodine, 
Honeywell Safety Products USA, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Splint First Aid Kit: 02-10-70X

Active ingredient

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

Purpose

First aid antiseptic

Uses

Warnings

For external use only

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

nonoxynol 9, water

Questions

1-800-430-5490

Principal Display Panel

Antiseptic Wipe PVP

SPLINTER FIRST AID KIT 
povidone iodine, kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-9002
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-9002-001 in 1 KIT12/29/2017
11 in 1 POUCH; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 POUCH 1 mL
Part 1 of 1
NORTH PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC:0498-0120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0120-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/29/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/29/2017
Labeler - Honeywell Safety Products USA, Inc (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc079287321pack(0498-9002)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical532775194manufacture(0498-0120)

Revised: 8/2018
Document Id: 74197d46-dfe0-87fb-e053-2991aa0a34fd
Set id: 61944af7-1304-c847-e053-2a91aa0ab8f6
Version: 4
Effective Time: 20180823
 
Honeywell Safety Products USA, Inc