NDC | 0498-0730-01, 0498-4185-01, 0498-4269-01 |
Set ID | 839cbf33-0017-f362-e053-2991aa0a17bf |
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 |
- First Aid Burn Cream Active ingredient
- First Aid Burn Cream Purpose
- First Aid Burn Cream Uses
- First Aid Burn Cream Warnings
- First Aid Burn Cream Directions
- First Aid Burn Cream Other information
- First Aid Burn Cream Inactive ingredients
- First Aid Burn Cream Questions
- BZK Antiseptic Wipe Active ingredient
- BZK Purpose
- BZK Uses
-
BZK
Warnings
For external use only
BZK
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
- BZK Directions
- BZK Other information
- BZK Inactive ingredients
- BZK Questions
- Sting Relief Active ingredient
- Sting Relief Purpose
- Sting Relief Uses
- Sting Relief Warnings
- Sting Relief Directions
- Sting Relief Inactive ingredients
- Sting relief Questions or Comments
- Neomycin Antibiotic Ointment Active ingredient
- Neomycin Antibiotic Ointment Purpose
- Neomycin Antibiotic Ointment Uses
- Neomycin Antibiotic Ointment Warnings
- Neomycin Antibiotic Ointment Directions
- Neomycin Antibiotic Ointment Other information
- Neomycin Antibiotic Ointment Inactive ingredient
- Neomycin Antibiotic Ointment Questions
-
4185
010100-4353L Kit Contents
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
1 GAUZE CLEAN-WRAP BDGE N/S 2"
1 ELASTIC BANDAGE 3" X 4.5YD
1 SCISSOR BDGE 4" RED PLS HDL
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
LBL STOCK 3"x1-7/8"
10 BZK ANTISEPTIC WIPE, BULK
2 PR LRG NITRILE GLVES ZIP BAG
3 FIRST AID CREAM 0.9GR PKT EACH
1 TAPE ADHESIVE 1/2 X 2.5 125133
3 POUCH NEOMYCIN ANTIBIOTIC .9 G
12 ADH PL LATEX FREE BAND
1 LBL #10 FRT COVER ID A
1 LBL #10 BACK ALL PURPOSE ID A
1 BAG ZIPPER POLY 6 X 6 2 MIL
2 SAFETEC STING RELIEF WIPES BULK
1 COLD PACK UNIT 4"X6" BULK
2 GAUZE PADS 2"X2" 12PLY
1 EYE PADS STD OVAL STERILE
1 GAUZE PADS 4"X4" 12PLY
45 PLASTIC BANDAGE 1" X 3"
2 WOVEN FINGERTIP BANDAGE 2"
2 WOVEN KNUCKLE BANDAGE
3 WOVEN BANDAGE 1" X 3"
3 BANDAGE, PATCH, ADHESIVE, 2X3
3 BNDG,PATCH,ADHESIVE,1.5X1.5
-
4269
SF00001071 kit contents
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
1 GAUZE CLEAN-WRAP BDGE N/S 2"
1 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
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 LBL NORTH CONTS 6.75X3.5 ID B
10 BZK ANTISEPTIC WIPE, BULK
4 PR LRG NITRILE GLVES ZIP BAG
1 1" X 3" PLASTIC BANDS 16/BAG
6 FIRST AID CREAM 1.0GR PKT EACH
1 TAPE ADHESIVE 1/2 X 2.5 125133
6 POUCH NEOMYCIN ANTIBIOTIC .9 G
1 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT, PP 10 UNIT FA
1 LBL 10P CVR NORTH ID B
1 BAG ZIPPER POLY 6 X 6 2 MIL
10 SAFETEC STING RELIEF WIPES BULK
2 TRI BNDG NON WOVEN 40"X40"X56"
1 COLD PACK UNIT 4"X6" BULK
4 GAUZE PADS 2"X2" 12PLY
4 GAUZE PADS 3"X3" 12PLY
1 WOVEN FINGERTIP BANDAGE 2"
- First Aid Burn Cream Principal Display Panel
- BZK Principal Display Panel
- Sting Relief Principal Display Panel
- Neomycin Antibiotic Ointment Principal Display Panel
- 4185 Kit Label 010100-4353L
- 4269 Kit Label SF00001071
-
INGREDIENTS AND APPEARANCE
4269 FIRST AID KIT
4269 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4269 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4269-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 10 POUCH 4 mL Part 2 6 PACKET 5.4 g Part 3 6 PACKET 5.4 g Part 4 10 PACKET 14 mL Part 1 of 4 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 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 2 of 4 FIRST AID BURN
benzalkonium chloride, lidocaine hydrochloride creamProduct Information Item Code (Source) NDC:0498-0903 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) METHYLPARABEN (UNII: A2I8C7HI9T) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) LIGHT MINERAL OIL (UNII: N6K5787QVP) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 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 3 of 4 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 4 of 4 ANTISEPTIC TOWELETTE
benzalkonium chloride liquidProduct 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 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4185 FIRST AID KIT
4185 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4185 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4185-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 POUCH 0.8 mL Part 2 3 PACKET 2.7 g Part 3 3 PACKET 2.7 g Part 4 10 PACKET 14 mL Part 1 of 4 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 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 2 of 4 FIRST AID BURN
benzalkonium chloride, lidocaine hydrochloride creamProduct Information Item Code (Source) NDC:0498-0903 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) METHYLPARABEN (UNII: A2I8C7HI9T) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) LIGHT MINERAL OIL (UNII: N6K5787QVP) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 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 3 of 4 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 4 of 4 ANTISEPTIC TOWELETTE
benzalkonium chloride liquidProduct 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 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 Labeler - Honeywell Safety Products USA, INC (079287321) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, INC 079287321 pack(0498-4185, 0498-4269) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0903, 0498-0730) Establishment Name Address ID/FEI Business Operations Changzhou Maokang Medical 421317073 manufacture(0498-0501) Establishment Name Address ID/FEI Business Operations Safetec of America Inc 874965262 manufacture(0498-0733)