NDC | 0498-0100-01, 0498-0121-00, 0498-0143-04, 0498-0203-00, 0498-0730-01, 0498-0733-00, 0498-4220-01 |
Set ID | 84af2106-e40f-67a9-e053-2991aa0ac68b |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic |
Product Number | |
Application Number |
- Burn Jel Active ingredient
- Burn Jel Purpose
- Burn Jel Uses
- Burn Jel Warnings
- Burn JEl Directions
- Burn Jel Other information
- Burn Jel Inactive ingredients
- Burn Jel Questions
- Sting Relief Active ingredient (in each wipe)
- Sting Relief Purpose
- Sting Relief Uses
- Sting Relief Warnings
- Sting Relief Directions
- Sting Relief Inactive ingredient
- Sting Relief Questions or Comments?
- PVP Active ingredient
- PVP Purpose
- PVP Uses
- PVP Warnings
- PVP Directioons
- PVP Other information
- PVP Inactive ingredients
- PVP Questions and Comments?
- Alcohol Active ingredient
- Alcohol Purpose
- Alcohol Uses
- Alcohol Warnings
- Alcohol Directioons
- Alcohol Other information
- Alcohol Inactive ingredient
- Neomycin Active ingredient
- Neomycin Purpose
- Neomycin Uses
- Neomycin Warnings
- Neomycin Directions
- Neomycin Other information
- Neomycin Inactive ingredient
- Neomycin Questions?
- Eyewash Active ingredient
- Eyewash Purpose
- Eyewash Uses
-
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
- Keep out of reach of children
- Eyewash Directions
- Eyewash Inactive ingredients
- Eyewash Questions?
-
4220
019643-4367 Kit Contents
1 KNUCKLE BAND 8 PER
1 NEOMYCIN ANTIBIOTIC 10 PER
1 GAUZE BANDAGE, 4" X 6 YD
2 TRIANGULAR BDG, NON-STERILE
1 GAUZE PADS, 3" X 3", 4 PER
1 ADHESIVE TPE 1"X2-1/2 YD 2 PER
2 INSTANT COLD PACK 4" X 6"
2 BANDAGE COMP, 2" OFFSET, 4 PER
2 BANDAGE COMP, 4" OFFSET, 1 PER
2 ADH BAND, EXTRA LARGE, 6 PER
2 1 OZ EYE WASH W/PADS & STRIPS
1 BURN JEL 1/8 OZ, 6 PER
5 WATER JEL DRESSING,2" X 6"
1 PVP IODINE WIPES 10 PER
2 NITRILE GLOVES 2PR BBP
2 ADH BDG, CLOTH, 1"X3", 16 PER
1 FIRST AID GUIDE ASHI
2 ABD COMBINE PAD 5" X 9"
1 MICROSHIELD W/VNL GLV/ALCL
1 SCISSOR BDGE 4" RED PLS HDL
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 STOCK LABEL 1 7/8" X 1/2"
1 LBL CONTS 8"X8",CUSTOM ID B
1 KIT 36 UNIT PLASTIC
1 STING Relief WIPES 10
- Burn Jel Principal Display Panel
- Sting Relief Principal Display Panel
- PVP Principal Display Panel
- Alcohol Principal Display Panel
- Neomycin Principal Display Panel
- Eyewash Principal Display Panel
- 4220 Kit Label 019643-4367
-
INGREDIENTS AND APPEARANCE
4220 FIRST AID KIT
4220 first aid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4220 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4220-01 1 in 1 KIT 09/13/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 PACKET 21 g Part 2 10 POUCH 4 mL Part 3 10 POUCH 3 mL Part 4 2 BOTTLE 60 mL Part 5 10 PACKET 9 g Part 6 1 POUCH 0.4 mL Part 1 of 6 BURN JEL
gel for burns gelProduct 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 STING RELIEF PAD
ethyl alcohol, lidocaine swabProduct 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 Part 3 of 6 PVP IODINE WIPE
povidone-iodine 10% swabProduct Information Item Code (Source) NDC:0498-0121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0121-00 0.3 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 unapproved drug other 09/18/2018 Part 4 of 6 EYESALINE EMERGENCY EYEWASH
purified water liquidProduct 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 5 of 6 NEOMYCIN
antibiotic ointmentProduct Information Item Code (Source) NDC:0498-0730 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0730-01 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 03/31/2010 Part 6 of 6 ALCOHOL WIPE
isopropyl alcohol swabProduct 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 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(0498-4220) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0203, 0498-0730) 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(0498-0143) Establishment Name Address ID/FEI Business Operations Sion Biotext Medical 532775194 manufacture(0498-0121) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 manufacture(0498-0733)