Label: 4362 FIRST AID KIT- 4362 first aid kit

  • NDC Code(s): 0498-0100-01, 0498-0121-00, 0498-0143-04, 0498-0501-00, view more
    0498-0733-00, 0498-0750-35, 0498-0801-35, 0498-3334-00, 0498-4362-01, 65753-100-37
  • 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 June 1, 2019

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

  • Burn Jel Active ingredient

    Lidocaine HCl 2.0%

  • Burn Jel Purpose

    External analgesic

  • Burn Jel Uses

    • temporarily relieves pain due to minor burns
  • 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.
  • 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

  • Triple Active ingredient

    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

  • Triple Questions?

    1-800-430-5490

  • Sting Relief Active ingredient (in each wipe)

    Ethyl alcohol 50.0%

    Lidocaine HCl 2.0%

  • Sting Relief Purpose

    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

  • 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

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

  • 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

  • Ammonia Active ingredient

    Ammonia 15%

  • Ammonia 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 Other information

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

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

  • Ammonia Questions or Comments?

    1-800-430-5490

  • Alcohol Active ingredient

    Isopropyl alcohol 70%

  • Alcohol Purpose

    First aid antiseptic

  • Alcohol Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • 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 reach of children

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

  • 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
  • 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 opened
  • Alcohol Inactive ingredient

    water

  • Alcohol Questions

    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

  • Sun X Active ingredients

    Avobenzone 1.0%

    Homosalate 5.0%

    Octinoxate 7.5%

    Octisalate 5.0%

    Oxybenzone 6.0%

  • Sun X Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

  • Sun X Uses

    • helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.
  • Sun X Warnings

    For external use only

    Do not use

    • on damaged or broken skin

    When using this product

    • keep out of the eyes
    • rinse with water to remove

    Stop use and ask a doctor if

    • rash occurs

    Keep out of the reach of children

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

  • Sun X Directions

    • apply liberally and evenly 15 minutes before sun exposure

    Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and after sun protection measures including:

    • limit time in the sun, especially from 10:00 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.
    • reapply:
      • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

    • children under 6 months of age: Ask a doctor
  • Sun X Other information

    • protect this product from excessive heat or direct sun
  • Sun x Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita extract, dimethicone, dimethyl capramide, ethylparaben, fragrance, glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale leaf extract, tetrasodium EDTA, triethanolamine, tocopherol, tocopherol acetate, water

  • Sun x Questions

    1-877-684-5774

  • 4293 SF00004080 Kit Contents

    1 FNGRTIP-5 PER, KNCKL BDG-4 PER

    1 TRIPLE ANTIBIOTIC 10 PER

    1 AMMONIA INHALANTS 10 PER

    1 EYE DRESS PKT W/4 ADH STRIPS

    1 TRIANGULAR BDG, NON-STERILE

    1 FORCEPS & SCISSORS, 1 EA

    1 GAUZE BANDAGE, 2" X 6 YD,2 PER

    1 INSTANT COLD PACK 4" X 6"

    1 ADH BDG W/NOADHR PAD,1X3 32PER

    1 BURN JEL 1/8 OZ, 6 PER

    1 ALCOHOL PREP PADS 10P

    1 HYDROCORTISON,1.O%,1/32 OZ,10P

    1 PVP IODINE WIPES 10 PER

    1 STING RELIEF WIPES 10 PER BOX

    1 ADH TAPE W/P 1/2"X 2 1/2 YD

    1 FIRST AID GUIDE ASHI

    1 1 OZ, BUFF EYEWASH

    1 BANDAGE COMP 4" W/TELFA PAD 1

    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

  • Burn Jel Principal Display Panel

    Burn Jel

  • Triple Principal Display Panel

    Triple Antibiotic

  • Sting Relief Principal Display Panel

    Sting Relief

  • Eyewash Principal Display Panel

    Eyesaline

  • Hydrocortisone Principal Display Panel

    Hydrocortisone Cream

  • Ammonia Principal Display Panel

    Ammonia Inhalant

  • Alcohol Principal Display Panel

    Alcohol Preps

  • PVP Principal Display Panel

    PVP Wipe

  • Sun X Principal Display Panel

    Sun X

  • 4293 Kit Label SF-00004080

    4293 label

  • INGREDIENTS AND APPEARANCE
    4362 FIRST AID KIT 
    4362 first aid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4362
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4362-011 in 1 KIT09/13/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 1.4 mL
    Part 21 BOTTLE 30 mL
    Part 310 PACKET 9 g
    Part 410 POUCH 4 mL
    Part 510 POUCH 4 mL
    Part 610 PACKET 9 g
    Part 710 AMPULE 3 mL
    Part 810 POUCH 3 mL
    Part 92 PACKET 88 mL
    Part 1 of 9
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2017
    Part 2 of 9
    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, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0100-0130 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 9
    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:0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/19/2018
    Part 4 of 9
    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 5 of 9
    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 6 of 9
    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
    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)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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 7 of 9
    AMMONIA INHALENT 
    ammonia inhalent inhalant
    Product Information
    Item Code (Source)NDC:0498-3334
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-3334-000.3 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/18/2018
    Part 8 of 9
    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 9 of 9
    CORETEX SUN X SPF 30 
    avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Item Code (Source)NDC:65753-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    Product Characteristics
    Colorwhite (Thick White Lotion) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-100-3744 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/25/2013
    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
    James Alexander040756421manufacture(0498-3334)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoreTex Products Inc061944620manufacture(65753-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321pack(0498-4362)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0750, 0498-0801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0143, 0498-0501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Medical Biotext532775194manufacture(0498-0121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America Inc874965262manufacture(0498-0733)