Label: 4138 FIRST AID KIT- 4138 first aid

  • NDC Code(s): 0498-0100-01, 0498-0143-04, 0498-0203-00, 0498-0501-00, view more
    0498-0733-00, 0498-0750-35, 0498-4138-01
  • 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 May 5, 2019

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

  • Burn Jel Active ingredient

    Lidocaine HCl 2.0%

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  • Burn Jel Purpose

    External analgesic

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  • Burn Jel Uses

    • temporarily relieves pain due to minor burns
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  • Burn Jel Warnings

    For external use only

    Do not use

    • on large areas of the body, particularly over raw surfaces or blistered areas

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • the condition gets worse
    • symptoms persist 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.
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  • Burn JEl Directions

    • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
    • you may report a serious reaction to this product to 800-430-5490
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  • Burn Jel Other information

    • store at room temperature - do not use if opened or torn
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  • Burn Jel Inactive ingredients

    carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water

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  • Burn Jel Questions

    1-800-430-5490

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  • Triple Active ingredient

    Bacitracin zinc 400 units

    Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

    Polymyxin B sulfate 5000 units

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  • Triple Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

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  • Triple Uses


    first aid to help prevent infection in:

    • minor cuts
    • scrapes
    • burns
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  • Triple Warnings

    For external use only

    Allergy alert: do not use if you are allergic to any of the ingredients

    Do not use

    • in the eyes
    • over large areas of the body
    • Ask a doctor before use if you have
    • a deep or puncture wounds
    • animal bites
    • serious burns


    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
    • you need to use longer than 1 week


    Keep out of the reach of children

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

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  • Triple Directions

    • clean the affected area
    • apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
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  • Triple Other information

    • store at 15 0 to 25 0 C (59 0 to 77 0 F)
    • tamper evident sealed packets
    • do not use if packet is torn or opened
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  • Triple Inactive ingredient

    petrolatum

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  • Triple Questions?

    1-800-430-5490

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  • BZK Wipe Active ingredient

    Benzalkonium chloride 0.13% w/v

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  • BZK Wipe Purpose

    First aid antiseptic

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  • BzK Wipe Uses

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

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  • BZK Wipe 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
    • longer than 1 week unless directed by 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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  • BZK Wipe Directions

    tear open packet and use as a washcloth

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  • BZK Wipe Other information

    • store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
    • do not reuse towelette
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  • BZK Wipe Inactive ingredient

    water

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  • BZK Wipe Questions

    1-800-430-5490

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  • Sting Relief Active ingredient (in each wipe)

    Ethyl alcohol 50.0%

    Lidocaine HCl 2.0%

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  • Sting Relief Purposse

    Antiseptic

    Topical pain relief

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  • Sting Relief Uses

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

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  • 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.

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  • Sting Relief Inactive ingredients

    benzalkonium chloride, menthol, and purified water

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  • Sting Relief Questions or Comments?

    1-800-430-5490

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  • Alcohol Active ingredient

    Isopropyl alcohol 70%

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  • Alcohol Purpose

    First aid antiseptic

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  • Alcohol Uses

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

    For external use only

    Flammable, keep away from fire and flame

    Do not use

    • in or near eyes
    • over large areas of the body



    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns



    When using this product

    • do not use longer than 1 week unless directed by a doctor

    Stop use and consult a doctor if

    • condition persists or gets worse

    Keep out of the reach of children

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

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  • Alcohol Directions

    • clean the affected area
    • may be covered with a sterile bandage
    • apply wipe to affeted are 1 to 3 times daily
    • discard wipe after single use
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  • Alcohol Other information

    • store at room temperature 15 0 to 25 0 C (59 0 to 77 0 F)
    • do not use if packet is torn or
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  • Alcohol Questions

    1-800-430-5490

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  • Eyewash Active ingredient

    Sterile Water 99%

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  • Eyewassh Purpose

    Eyewash

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  • Eyewash Uses

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

    For external use only

    • Obtain immediate medical treatment for all open wounds in or near eyes.
    • To avoid contamination, do not touch tip of container to any surface.
    • Do not reuse.
    • Once opened, discard.

    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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  • Eyeash 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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  • Eyewash Inactive ingredients

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

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  • Eyeash Questions

    Call 1-800-430-5490 Honeywell Safety Products USA, Inc. Smithfield, RI 02917

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  • 4138 SF00002053 kit contents

    1 TRIPLE ANTIBIOTIC 10 PER

    1 TRIANGULAR BDG, NON-STERILE

    1 GAUZE PADS, 3" X 3", 4 PER

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

    1 GAUZE COMP, 1 SQ YARD, 1 PER

    1 INSTANT COLD PACK 4" X 6"

    1 BANDAGE COMP, 2" OFFSET, 4 PER

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

    1 1 OZ EYE WASH W/PADS & STRIPS

    1 BURN JEL 1/8 OZ, 6 PER

    1 ALCOHOL PREP PADS 10P

    1 NITRILE GLOVES 2PR BBP

    1 ANTIMCRBL ANTSPTC TWLETTS

    1 FIRST AID GUIDE ASHI

    1 CPR MICROSHIELD DOUBLE UNIT

    LBL STOCK 6-3/8"X4"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    1 KIT STL 24 UN WHITE 01

    1 STING Relief WIPES 10

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  • Burn Jel Principal Display Panel
  • Triple Principal Display Panel
  • BZK Wipe Principal Display Panel
  • Sting Relief Principal Display Panel
  • Alcohol Principal Display Panel
  • Eyewash Principal Display Panel
  • 4138 Kit Label SF00002053
  • INGREDIENTS AND APPEARANCE
    4138 FIRST AID KIT 
    4138 first aid kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4138
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4138-01 1 in 1 KIT 09/13/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 6 PACKET 21 g
    Part 2 1 BOTTLE 30 mL
    Part 3 10 PACKET 9 g
    Part 4 1 PACKET 1.4 mL
    Part 5 10 POUCH 4 mL
    Part 6 10 POUCH 4 mL
    Part 1 of 6
    BURN JEL 
    gel for burns gel
    Product Information
    Item Code (Source) NDC:0498-0203
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0203-00 3.5 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 part348 09/19/2018
    Part 2 of 6
    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 PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    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 3 of 6
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
    Product Information
    Item Code (Source) NDC:0498-0750
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0750-35 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 final part333B 09/19/2018
    Part 4 of 6
    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 12/22/2017
    Part 5 of 6
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source) NDC:0498-0143
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0143-04 0.4 mL in 1 POUCH; 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 09/18/2018
    Part 6 of 6
    STING RELIEF PAD 
    ethyl alcohol, lidocaine swab
    Product Information
    Item Code (Source) NDC:0498-0733
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0733-00 0.4 mL in 1 POUCH; 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 part348 12/23/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/13/2018
    Labeler - Honeywell Safety Products USA, Inc. (079287321)
    Registrant - Honeywell Safety Products USA, Inc. (079287321)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc 079287321 pack(0498-4138)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(0498-0203, 0498-0750)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100)
    Establishment
    Name Address ID/FEI Business Operations
    Changzhou Maokang Medical 421317073 manufacture(0498-0501, 0498-0143)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America Inc 874965262 manufacture(0498-0733)
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