Label: 4357 FIRST AID KIT kit

  • NDC Code(s): 0498-0021-40, 0498-0100-02, 0498-0143-04, 0498-0203-00, view more
    0498-0750-36, 0498-0800-35, 0498-0801-35, 0498-4357-01
  • 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 October 16, 2019

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

  • Eyewash Active ingredient

    Sterile Water 99%

  • Eyewash Purpose

    Eyewash

  • Eyewash Uses

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

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

  • Eyewash Questions

    1-800-430-5490

  • Burn Relief Water Soluble Active ingredients

    Benzethonium chloride 0.2% w/w

    Benzocaine 10% w/w

    Menthol 0.33% w/w

  • Burn Relief Water Soluble Purpose


    Topical antiseptic

    Topical anesthetic

    Topical anesthetic

  • Burn Relief Water Soluble Uses

    for the temporary relief of pain and itching and helps protect against infection in:

    • minor cuts and scrapes
    • burns
    • sunburn
    • insect bites
    • minor skin irritations
  • Burn Relief Water Soluble Warnings

    For external use only

    Flammable keep away from fire or flame

    • contents under pressure
    • do not puncture or incinerate container
    • do not expose to temperatures above 120 0 F

    Do not use

    • in or near the eyes or other mucous membranes
    • in case of serious burns
    • in case of deep or puncture wounds
    • for prolonged period of time
    • on large portion of the body

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • condition clears up and recurs within a few days
    • redness, swelling, or irritation occurs

    Keep out of the reach of children

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

  • Burn Relief Water Soluble Directions

    • clean the affected area
    • shake can well before using
    • hold 4 - 6 inches from surface and spray area until wet
    • may be covered with a sterile bandage, if bandaged let dry first
    • for adult institutional use only
    • not intended for use on children
  • Burn Relief Water Soluble Other information

    • avoid inhaling
    • use only as directed
    • intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal
  • Burn Relief Water Soluble Inactive ingredients

    dipropylene glycol, isobutane, n-butane, propane

  • Triple Active ingredients

    Bacitracin zinc 400 units

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

    Polymyxin B sulfate 5000 units

  • Triple Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

  • Triple Uses

    • first aid to help prevent infection in
    • minor cuts
    • scrapes
    • burns
  • 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.

  • 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
  • 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
  • Triple Inactive ingredient

    petrolatum

  • Alcohol Active ingredient

    Isopropyl alcohol 70%

  • Alcohol Purpose

    First aid antiseptic

  • Alcohol Uses

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

    For external use only

    Flammable, keep away from fire or flame.

    Do not use

    • in the 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 one week unless directed by a doctor

    Stop use and consult a doctor

    • if condition persists or gets worse

    Keep out of reach of children

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

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

    store at room temperature 15 0 to 25 0 C (59 0 to 77 0 F)

  • Alcohol Inactive ingredient

    water

  • Hydrocortisone Active ingredient (in each gram)

    Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

  • Hyrdocortisone 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

  • Foille Active ingredient


    Benzocaine 5.0% (w/w)

    Chloroxylenol 0.1% (w/w)

  • Foille Purpose

    External analgesic

    Antiseptic

  • Foille Uses

    • For the temporary relief of pain associated with burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
    • First aid to help prevent infection in minor cuts, scrapes and burns.
  • Foille Warnings

    For external use only

    When using this product

    • avoid contact with the eyes

    Stop use and ask a doctor if

    • condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days.
    • Do not apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

    Keep out of reach of children.

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

  • Foille Directions

    • clean the affected area.
    • 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: consult a physician.
  • Foille Other information

    Avoid contact with clothing

    Foille may stain certain fabrics

  • Foille Inactive ingredients

    beeswax, benzyl alcohol, calcium disodium EDTA, calcium hydroxide, ceresin, eugenol, hydrogenated vegetable oil, maleic anhydride, mono- and di-glycerides, PEG-32, purified water, sodium borate, sodium lauryl sulfate, zea mays (corn) oil.

  • Burn Jel Active ingredient

    Lidocaine HCl 2.0 %v

  • Burn Jel Purpose

    External analgesic

  • Burn Jel Uses

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

    For external use oonly

    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.

  • 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
  • Burn Jel Other information

    • store at room temperature - do not use if opened or torn
  • 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

  • Burn Jel Questions

    1-800-430-5490

  • 4357 6832649 KIT CONTENTS

    1 BLUE DETEC FNGERTP 8 WVN 25/B

    1 BLUE DETEC KNUCKLE WVN 40/BX

    1 BLUE DETEC 1X3 WVN 100/BX

    1 INSTANT COLD PACK 4" X 6"

    5 BURN JEL 1/8 OZ, 6 PER

    1 ADHESIVE TAPE W/P 1/2"X 5 YD

    1 FIRST AID GUIDE ASHI

    1 GAUZE CLEAN-WRAP BDGE N/S 2"

    1 GZE PADS STERILE 2"X 2" 25'S

    1 GZE PADS STERILE 3"X 3" 25'S

    1 CO-FLEX BANDAGE 2"X 5YDS TAN

    1 ALCOHOL WIPES 50'S

    1 TRIPLE BIOTIC .5 GRAM PKT 20

    1 HYDROCORTISONE 1% .9 GRM 20'S

    1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

    1 SCISSOR BDGE 4" RED PLS HDL

    1 SPLINTER OUT 10 PIECES/PK

    1 KIT TWEEZER 3 1/2" SLANTED

    1 F A KIT EMPTY BLANK 140

    1 LBL STOCK 6-3/8"X4"

    1 LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    2 PR LRG NITRILE GLVES ZIP BAG

    5 WATER-JEL BURN DRESSING 4 X 4

    3 FOILLE BURN .5OZ 2'S

  • Eyewash Principal Display Panel

    Eyesaline

  • Burn Relief Water Soluble Principal Display Panel

    Burn WS label

  • Triple Principal Display Panel

    Triple Antibiotic

  • Alcohol Principal Display Panel

    Alcohol Preps

  • Hydrocortisone Principal Display Panel

    Hydrocortisone

  • Foille Principal Display Panel

    Foille

  • Burn Jel Principal Display Panel

    Burn Jel

  • 4357 Kit Label 6832649

    4357 label

  • INGREDIENTS AND APPEARANCE
    4357 FIRST AID KIT 
    4357 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4357
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4357-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 120 PACKET 18 g
    Part 21 BOTTLE 118 mL
    Part 31 CAN 85 g
    Part 420 PACKET 10 g
    Part 550 POUCH 20 mL
    Part 620 PACKET 18 g
    Part 76 TUBE 84 g
    Part 830 PACKET 105 g
    Part 1 of 8
    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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0801-350.9 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
    Part 2 of 8
    EYESALINE EMERGENCY EYEWASH 
    purified water liquid
    Product Information
    Item Code (Source)NDC:0498-0100
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0100-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/18/2018
    Part 3 of 8
    BURN WATER SOLUBLE 
    benzocaine, benzethonium chloride, menthol spray
    Product Information
    Item Code (Source)NDC:0498-0021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.33 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0021-4085 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/12/2018
    Part 4 of 8
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
    Product Information
    Item Code (Source)NDC:0498-0750
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0750-360.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/19/2018
    Part 5 of 8
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:0498-0143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0143-040.4 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 finalpart333A09/18/2018
    Part 6 of 8
    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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0800-350.9 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 7 of 8
    BLISTEX  FOILLE MEDICATED FIRST AID
    benzocaine and chloroxylenol ointment
    Product Information
    Item Code (Source)NDC:10157-9302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CERESIN (UNII: Q1LS2UJO3A)  
    EUGENOL (UNII: 3T8H1794QW)  
    MALEIC ANHYDRIDE (UNII: V5877ZJZ25)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    CORN OIL (UNII: 8470G57WFM)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/05/2013
    Part 8 of 8
    BURN JEL 
    gel for burns gel
    Product Information
    Item Code (Source)NDC:0498-0203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0203-003.5 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 finalpart34809/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2018
    Labeler - Honeywell Safety Products USA, INC (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354manufacture(10157-9302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, INC079287321pack(0498-4357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments115315822manufacture(0498-0021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0750, 0498-0800, 0498-0203, 0498-0801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0143)