NDC | 0498-0100-01, 0498-0121-00, 0498-3334-00, 0498-4208-01 |
Set ID | 84170c4e-10ba-12ac-e053-2991aa0a2299 |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, INC |
Generic Name | |
Product Class | Amide Local Anesthetic, 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
- Ammonia Inhalent Active ingredient (in each ampule)
- Ammonia Inhalent Purpose
- Ammonia Inhalent Uses
- Ammonia Inhalent Warnings
- Ammonia Inhalent Directions
- Ammonia Inhalent Other information
- Ammonia Inhalent Inactive ingredients
- Ammonia Inhalent 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.
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.
- Eyewash Directions
- Eyewash Inactive ingredients
- Eyewash Questions
- PVP Active Ingredient
- PVP Purpose
- PVP Uses
- PVP Warnings
- Keep out of reach of children.
- PVP Directions
- PVP Other informatiion
- PVP Inactive ingredient
- PVP Questions
-
4208
019736-0023L Kit Contents
1 KNUCKLE BAND 8 PER
3 FIRST AID BURN CREAM 6 PER
1 AMMONIA INHALANTS 10 PER
2 EYE DRESS PKT W/4 ADH STRIPS
1 GAUZE PADS, 3" X 3", 4 PER
1 ADHESIVE TPE 1"X2-1/2 YD 2 PER
1 GAUZE BANDAGE, 2" X 6 YD,2 PER
2 BUFFERED EYE WASH 1 OZ BTL
1 BANDAGE COMP, 2" OFFSET, 4 PER
1 BANDAGE COMP, 4" OFFSET, 1 PER
4 ADHESIVE BDG,PLSTIC,1"X3"16PER
1 ADH BAND, EXTRA LARGE, 6 PER
2 PVP IODINE WIPES 10 PER
1 NITRILE GLOVES 2PR BBP
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
LBL STOCK 6-3/8"X4"
LBL STOCK 3"x1-7/8"
1 LABEL NORTH CONTENTS 8X8 ID B
1 KIT STL 24 UN WHITE 01
1 LABEL 24U CVR NORTH WELDERS
- First Aid Burn Cream Principal Display Panel
- Ammonia Inahalent Principal Display Panel
- Eyewash Principal Display Panel
- PVP Principal Display Panel
- 4208 Kit Label 019736-0023L
-
INGREDIENTS AND APPEARANCE
4208 FIRST AID KIT
4208 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4208 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4208-01 1 in 1 KIT; Type 0: Not a Combination Product 03/14/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 18 PACKET 16.2 g Part 2 10 AMPULE 3 mL Part 3 2 BOTTLE 60 mL Part 4 20 POUCH 6 mL Part 1 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 2 of 4 AMMONIA INHALENT
ammonia inhalent inhalantProduct Information Item Code (Source) NDC:0498-3334 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g in 0.3 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-3334-00 0.3 mL in 1 AMPULE; 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 3 of 4 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, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) 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 4 of 4 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/14/2019 Labeler - Honeywell Safety Products USA, INC (079287321) Establishment Name Address ID/FEI Business Operations James Alexander 040756421 manufacture(0498-3334) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, INC 079287321 pack(0498-4208) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0903) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100) Establishment Name Address ID/FEI Business Operations Sion Biotext Medical 532775194 manufacture(0498-0121)