Label: 4348 FIRST AID KIT- 4348 first aid kit

  • NDC Code(s): 0498-0121-00, 0498-0733-00, 0498-0800-34, 0498-4348-01
  • Packager: Honeywell Safety Products USA, Inc.
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated October 16, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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

    • prevent infection in minor scrapes, and temporary relief of itching of insect bites
  • 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

    • adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.
    • children under 2 years of age: consult a doctor.

  • 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

    • for the temporary relief of itching associated with minor skin irritations and rashes
  • 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

    • adults and children 2 years and older:
    • clean the affected area
    • apply to the area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor
  • Hydrocortisone Other information

    • store at room temperature (do not freeze)
  • 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

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

    • 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
  • PVP 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

  • 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

  • INGREDIENTS AND APPEARANCE
    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)