Label: 4396 FIRST AID KIT kit

  • NDC Code(s): 0498-0121-00, 0498-0121-34, 0498-4396-01
  • Packager: Honeywell Safety Products USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 January 22, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • PVP Wipes Active ingredient

    Povidone-iodine 10%

    (equivalent to 1% titratable iodine)

  • PVP Wipes Purpose

    First aid antiseptic

  • PVP Wipes Uses

    • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
  • PVP Wipes 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 Wipes 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 Wipes 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 Wipes Inactive ingredients

    nonoxynol 9, water

  • PVP Wipes Questions

    800-430-5490

  • Burn Cream Active ingredient

    Benzalkonium chloride 0.13%

    Lidocaine hydrochloride 0.5%

  • Burn Cream Purpose

    First aid antiseptic

    External analgesic

  • Burn Cream Uses

    • prevent skin infection
    • for temporary relief of pain associated with miinor burns
  • Burn Cream Warnings

    For external use only

    Do not use

    • in or near the eyes
    • if you are allergic to any of the ingredients
    • in large areas of the body particularly over raw surfaces or blistered areas
    • for more than 10 days

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition persists
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of chidren

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

  • Burn Cream Directions

    • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (equal to the area of the tip of finger) onto the affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: ask a doctor
  • Burn Cream Other information

    • tamper evident sealed packets
    • do not use if packet is opened or torn
  • Burn Cream Inactive ingredients

    aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

  • Burn Cream Questions

    1-800-430-5490

  • Active ingredient Ammonia 15%

  • Purpose Respiratory stimulant

  • Ammonia Uses

    • to prevent or treat fainting
  • Ammonia Warnings

    For external use only

    Do not use

    • if you have breathing problems such as asthma or emphysema

    Stop use and ask a doctor if

    • condition persists

    Keep out of reach of children

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

  • Ammonia Directions

    • hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated on sleeve.
    • hold near nostrils for inhalation of volatile vapor
  • Ammonia Otheer information

    • store at room temperature away from light
  • Ammonia Innactive ingredients

    alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

  • Ammonia Questions or Comments?

    1-800-430-5490

  • 4396 011798-1494 Kit Contents

    1 43 LBL KIT BOX 011798-1494

    1 44 LBL BOEING WARNING

    1 237 LBL INNER 011798-1494

    1 201 LBL OUTER 011798-1494

    1 FIRST AID BURN CREAM 6 PER

    1 AMMONIA INHALANTS 10 PER

    4 GAUZE BANDAGE, 4" X 6 YD

    5 TRIANGULAR BDG, NON-STERILE

    2 WIRE SPLINT 1 PER

    1 ADHESIVE TPE 1"X2-1/2 YD 2 PER

    8 BANDAGE COMP, 4" OFFSET, 1 PER

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

    2 PVP IODINE WIPES 10 PER

    1 SCISSOR BDGE 4" RED PLS HDL

    LBL STOCK 6-3/8"X4"

    1 LBL STOCK 6-3/8"X4"

    1 LBL STOCK 3"x1-7/8"

    1 STOCK LABEL 1 7/8" X 1/2"

    1 PR LRG NITRILE GLVES ZIP BAG

    1 KIT STL 24 UN WHITE 01

    1 LABL INSTR 24 & 36 UNIT KITS

  • Honeywell PVP Wipes

    Honeywell PVP wipe

  • Burn Cream Principal Display Panel

    Burn Cream

  • Ammonia Principal Display Panel

    Ammonia Inhalent

  • 4396 Kit Label 011798-1494

    4396 label

  • INGREDIENTS AND APPEARANCE
    4396 FIRST AID KIT 
    4396 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4396
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4396-011 in 1 KIT11/21/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 120 POUCH 6 mL
    Part 26 PACKET 5.4 g
    Part 1 of 2
    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
    Part 2 of 2
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    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
    unapproved drug other12/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/21/2018
    Labeler - Honeywell Safety Products USA, Inc (118768815)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!