NDC | 0498-0100-01, 0498-0121-00, 0498-0143-04, 0498-0733-00, 0498-3334-00, 0498-4190-01 |
Set ID | 850a550b-a885-a375-e053-2991aa0a723b |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, INC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number |
- 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
- Alcohol Active ingredient
- Alcohol Purpose
- Alcohol Uses
- Alcohol Warnings
- Sting Relief Active ingredient (in each wipe)
- Sting Relief Purpose
- Sting Relief Uses
- Sting Relief Warnings
- Sting Relief Directions
- Sting Relief Inactive ingredients
- Sting Relief Questions or comments?
-
4190
010885-4514 Kit Contents
1 AMMONIA INHALANTS 10 PER
1 TRIANGULAR BDG, NON-STERILE
1 GAUZE COMPRESS, 1728 SQ IN 1
1 ADHESIVE TPE 1"X2-1/2 YD 2 PER
1 ADH BDG W/NOADHR PAD,1X3 32PER
1 BANDAGE COMP, 4" OFFSET, 1 PER
1 1 OZ EYE WASH W/PADS & STRIPS
1 PVP IODINE WIPES 10 PER
1 ELASTIC BANDAGE 3" X 4.5YD
1 MICROSHIELD W/VNL GLV/ALCL
1 NORTH RESPONSE REFILL/KIT
1 SCISSOR BDGE 4" RED PLS HDL
LBL STOCK 6-3/8"X4"
1 LBL STOCK 3"x1-7/8"
1 KIT STL 24 UN WHITE 01
1 LABL INSTR 24 & 36 UNIT KITS
1 STING RELIEF 10
- Ammonia Inahalent Principal Display Panel
- Eyewash Principal Display Panel
- PVP Principal Display Panel
- Sting Relief Principal Display Panel
- 4190 Kit Label 010885-4514
-
INGREDIENTS AND APPEARANCE
4190 FIRST AID KIT
4190 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4190 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4190-01 1 in 1 KIT; Type 0: Not a Combination Product 03/14/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 10 AMPULE 3 mL Part 2 1 BOTTLE 30 mL Part 3 10 POUCH 3 mL Part 4 10 POUCH 4 mL Part 5 10 POUCH 4 mL Part 1 of 5 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 2 of 5 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 3 of 5 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 5 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 Part 5 of 5 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 ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL in 1 mL LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg 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 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(0498-4190) 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)