Label: 4121 FIRST AID KIT- 4121 fist aid

  • NDC Code(s): 0498-0100-01, 0498-0501-00, 0498-3334-00, 0498-4121-01
  • 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 23, 2019

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  • Eyesaline Active ingredient

    Sterile water 99%

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  • Eyesaline Purpose

    Eyewash

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  • Eyesaline Uses

    • for flushing the eye to remove loose foreign material, air pollutants, or chlorinated water
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  • Eyesaline Warnings

    For external use only

    Do not use

    • if solution changes color or becomes cloudy
    • if you have open wounds in or near the eyes, get medical help right away.

    Stop use and ask a doctor if

    • you experience eye pain
    • changes in vision
    • continued redness or irritation of the eye
    • condition worsens or persists

    Keep out of reach of children

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

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  • Eyesaline Directions

    • remove contacts before using
    • twist top to remove
    • flush the affected area as needed
    • control rate of flow by pressure on the bottle
    • if necessary, continue flushing with emergency eyewash or shower
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  • Eyesaline Inactive ingredients

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

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  • Eyesaline Questions

    1-800-430-5490

    Honeywell Safety Products USA, Inc. Smithfield, RI 02917

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  • Antiseptic Towelette Active ingredient

    Benzalkonium chloride 0.13%

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  • Antiseptic Towelette Purpose

    First aid antiseptic

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  • Antiseptic Towelette Uses


    antiseptic cleansing of face, hands, and body without soap and water

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  • Antiseptic Towelette Warnings

    For external use only

    Do not use

    • in the eyes or over large areas of the body
    • on mucous membranes
    • on irritated skin
    • in case of deep puncture wounds, animal bites or serious burns, consult a doctor

    Stop use and ask a doctor if

    • if irritation, redness or other symptoms develop
    • the condition persists or gets worse

    Keep out of reach of children

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

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  • Antiseptic Towelette Directions

    • tear open packet and use as a washcloth
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  • Antiseptic Towelette Other information

    • store at room temperature 15 o to 30 oC (59 o - 86 oF)
    • do not reuse towelette
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  • Antiseptic Towelette Inactive ingredient

    water

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  • Antiseptic Towelette Questions

    1-800-430-5490

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  • First Aid Burn Cream Active ingredients

    Benzalkonium chloride 0.13%

    Lidocaine HCl 0.5%

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  • First Aid Burn Cream Purpose

    First Aid antiseptic

    External analgesic

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  • First Aid Burn Cream Uses

    prevent skin infection

    for temporary relief of pain associated with minor burns

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  • First Aid Burn Cream Warnings

    For external use only

    Do not use

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

    Keep out of reach of children

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

    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
    • symptoms persist for more than 7 days or clear up and occurs again within a few days
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  • First Aid 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 surface area of the tip of a finger) onto affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: consult a doctor
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  • First Aid Burn Cream Other information

    • tamper evident sealed packets
    • do not use if packet is opened or torn
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  • First Aid 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

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  • First Aid Burn cream Questions

    1-800-430-5490

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  • Ammonia Inhalent Active ingredient (in each ampule)

    Ammonia 15%

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  • Ammonia Purpose

    Respiratory stimulant

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  • Ammonia Uses

    • to prevent or treat fainting
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  • Ammonia Warnings

    For external use only

    Do not use

    • if you have breathing problems such as asthma or emphysema

    Keep out of reach of children

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

    Stop use and ask a doctor if

    • condition persists
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  • 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
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  • Ammonia Other information

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

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

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  • Ammonia Questions or Comments

    1-800-430-5490

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  • 4121 680025SM Kit Contents

    1 3/4X3 PLAS SING 50/BOX
    1 SWIFT WOVEN ASSORTED 20/BX
    1 GAUZE BANDAGE, 4" X 6 YD
    1 INSTANT COLD PACK 4" X 6"
    1 ADHES TAPE W/P 1"X 2 1/2 YD
    1 GAUZE CLEAN-WRAP BDGE N/S 2"
    1 ABD COMBINE PAD 5" X 9"
    1 1 OZ.EYEWASH
    1 SCISSOR BDGE 4" RED PLS HDL
    1 KIT TWEEZER 3 1/2" SLANTED
    1 # 25 EMPTY NO LOGO BLANK
    1 F. A. INST CHART SM (INDIVIDUAL LBL)
    1 FIRST AID PACK FOR 25 STANDARD
    1 TRI BNDG NON WOVEN 40"X40"X56"

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  • Principal Display Panel Eyesaline
  • Principal Display Panel Antiseptic Towelette

    Antiseptic Wipe1

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  • Principal Display Panel First Aid Burn Cream
  • Principal Display Panel Ammonia Inhalent

    Ammonia Inhalent1

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  • 4121 Kit Label 680025M Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    4121 FIRST AID KIT 
    4121 fist aid kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4121
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4121-01 1 in 1 KIT 01/24/2019
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE 30 mL
    Part 2 6 PACKET 8.4 mL
    Part 3 6 PACKET 5.4 g
    Part 4 2 AMPULE 0.6 mL
    Part 1 of 4
    EYESALINE EMERGENCY EYEWASH 
    purified water liquid
    Product Information
    Item Code (Source) NDC:0498-0100
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0100-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 12/18/2018
    Part 2 of 4
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0501-00 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Part 3 of 4
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 4 of 4
    AMMONIA INHALENT 
    ammonia inhalent inhalant
    Product Information
    Item Code (Source) NDC:0498-3334
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g  in 0.3 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-3334-00 0.3 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/18/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/24/2019
    Labeler - Honeywell Safety Products USA, Inc. (079287321)
    Establishment
    Name Address ID/FEI Business Operations
    James Alexander 040756421 manufacture(0498-3334)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc. 079287321 pack(0498-4121)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(0498-0903)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100)
    Establishment
    Name Address ID/FEI Business Operations
    Changzhou Maokong Medical 421317073 manufacture(0498-0501)
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