4348 FIRST AID KIT- 4348 first aid 
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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4348 First Aid Kit (HC cr, PVP wipes, sting relief- 013058-4344)

Sting Relief
Active ingredient (in each wipe)

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

Sting Relief
Purposse

Antiseptic

Topical pain relief

Sting Relief
Uses

Sting Relief
Warnings

For external use only


Flammable, keep away from open fire or flame

Do not use

  • over large areas of the body
  • in eyes
  • over raw or blistered areas

Stop use and ask a doctor

  • if conditions worsen or persist for more than 7 days or clear up and occur again within a few days


Keep out of reach of children.

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

Sting Relief
Directions

Sting Relief
Inactive ingredients

benzalkonium chloride, menthol, and purified water

Sting Relief
Questions or Comments?

1-800-430-5490

Hydrocortisone
Active ingredient (in each gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Hydrcortisone
Purpose

Anti-itch cream

Hydrocortisone
Uses

Hydrocortisone
Warnings


For external use only

Ask a doctor before use if

  • you are using any other hydrocortisone product

When using the product

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • do not use for the treatment of diaper rash

Stop use and ask a doctor if

  • condition worsens
  • condition persists for more than 7 days
  • condition clears up and recurs within a few days

Keep out of reach of children

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

Hydrocortisone
Directions

Hydrocortisone
Other information

Hydrocortisone
Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Hydrocortisone
Questions or Comments?

1-800-430-5490

PVP
Active ingredient

Povidone-iodine 10% (equivalent to 1% titratable iodine)

PVP
Purpose

First aid antiseptic

PVP
Uses

PVP
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.

PVP
Directions

PVP
Other information

PVP

Inactive ingredients

nonoxynol 9, water

4348
013058-4344 Kit Contents

1 TRIANGULAR BDG, NON-STERILE

1 GAUZE COMPRESS, 1728 SQ IN 1

1 ADHESIVE BDG,PLSTIC,1"X3"16PER

1 TOPICAL COOLING JEL

1 HYDROCORTISON,1.O%,1/32 OZ,10P

1 PVP IODINE WIPES 10 PER

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

1 PR LRG NITRILE GLVES ZIP BAG

1 KIT STL 10 UN WHITE 01

1 STING Relief WIPES 10

Sting Relief
Principal Display Panel

Sting Relief

Hydrocortisone
Principal Display Panel

Hydrocortisone Cream

PVP
Principal Display Panel

PVP Wipe

4348 Kit Label
013058-4344

4348 label

4348 FIRST AID KIT 
4348 first aid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4348
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4348-011 in 1 KIT09/13/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 110 POUCH 4 mL
Part 210 PACKET 9 g
Part 310 POUCH 3 mL
Part 410 PACKET 9 g
Part 1 of 4
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0733-000.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/23/2017
Part 2 of 4
HYDROCORTISONE 
anti-itch cream ointment
Product Information
Item Code (Source)NDC:0498-0800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0800-340.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/06/201310/15/2019
Part 3 of 4
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
WATER (UNII: 059QF0KO0R)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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
Part 4 of 4
HYDROCORTISONE 
anti-itch cream
Product Information
Item Code (Source)NDC:0498-0801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/13/2018
Labeler - Honeywell Safety Products USA, Inc. (079287321)
Registrant - Honeywell Safety Products USA, Inc. (079287321)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc079287321pack(0498-4348)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0800, 0498-0801)
Establishment
NameAddressID/FEIBusiness Operations
Sion Medical Biotext532775194manufacture(0498-0121)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America Inc874965262manufacture(0498-0733)

Revised: 10/2019
Document Id: 950f16c3-f039-a2ac-e053-2995a90a2d01
Set id: 89cef192-173a-edbd-e053-2a95a90abe98
Version: 2
Effective Time: 20191016
 
Honeywell Safety Products USA, Inc.