4046 First Aid Kit (PVP- SF00004727)

Drug Labeling and Warnings

Drug Details [pdf]

4046 FIRST AID KIT- 4046 first aid kit 
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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4046 First Aid Kit (PVP- SF00004727)

Active ingredient

Povidone-iodine 10%

(equivalent to 1% titratable iodine)

Purpose

First aid antiseptic

Uses

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

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

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

Other 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

Inactive ingredients

nonoxynol 9, water

Questions

800-430-5490

4046
SF00004727 Kit Contents

TRIANGULAR BDG MUSLIN 1 PER

ADH TAPE, .5" X 2.5 YD, 2 PER

GAUZE COMPRESS, 1728 SQ IN 1

GAUZE PADS, 4" X 4", 2 PER

INSTANT COLD PACK 4" X 6"

ADHESIVE BDG,PLSTIC,1"X3"16PER

TOPICAL COOLING JEL

PVP IODINE WIPES 10 PER

FIRST AID GUIDE ASHI

CPR MICROSHIELD W/2 PR LTX GLV

Honeywell PVP Wipes

Honeywell PVP wipe

4046 Kit Label
SF00004727

4046 kit label

4046 FIRST AID KIT 
4046 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0498-4046
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-4046-011 in 1 KIT; Type 0: Not a Combination Product11/21/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 110 POUCH 3 mL
Part 1 of 1
PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC: 0498-0121
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: 0498-0121-3410 in 1 CARTON
1NDC: 0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/21/201810/18/2019
Labeler - Honeywell Safety Products USA, Inc (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc079287321pack(0498-4046)

Revised: 10/2019
Document Id: 953798bb-e246-337e-e053-2995a90a0194
Set id: 7b346062-54ca-d870-e053-2a91aa0ab92b
Version: 3
Effective Time: 20191018