NDC | 0498-0100-01, 0498-0121-00, 0498-4130-01, 0498-4294-01 |
Set ID | 8781f56d-1177-0df3-e053-2a95a90a8971 |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- 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
- PVP Directions
- PVP Other information
- PVP Inactive ingredients
- PVP Questions
-
4130
SF00004222 kit contents
2 TRIANGULAR BDG, NON-STERILE
1 GAUZE COMPRESS, 1728 SQ IN 1
1 BUFFERED EYE WASH 1 OZ BTL
2 ADHESIVE BDG,PLSTIC,1"X3"16PER
1 TWEEZER PLASTICS 4"
1 CPR MICROSHIELD DOUBLE UNIT
1 SCISSOR BDGE 4" RED PLS HDL
2 BANDAGE COMP 2" W/TELFA PAD 4
1 BANDAGE COMP 3" W/TELFA PAD 2
LBL STOCK 6-3/8"X4"
1 LBL STOCK 3"x1-7/8"
2 PR LRG NITRILE GLVES ZIP BAG
1 KIT STL 16 UN (VERTICAL)
1 WOVEN KNUCKLE 8'S
2 PVP IODINE SWABS 10
-
4294
SF00004164 Kit Contents
1 TRIANGULAR BDG, NON-STERILE
1 GAUZE COMPRESS, 1728 SQ IN 1
1 BANDAGE COMP, 2" OFFSET, 4 PER
1 BANDAGE COMP, 3" OFFSET, 2 PER
1 ADHESIVE BDG,PLSTIC,1"X3"16PER
1 FINGERTIP BANDAGE, 10 PER
1 1 OZ EYE WASH W/PADS & STRIPS
1 PVP IODINE WIPES 10 PER
1 NITRILE GLOVES 2PR BBP
1 CPR MICROSHIELD DOUBLE UNIT
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
LBL STOCK 6-3/8"X4"
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 3"x1-7/8"
1 KIT STL 10 UN WHITE 01
1 LABL INSTR FA REV A
1 44 LABL FILL 10 UN XCEL ENERGY
- Eyewash Principal Display Panel
- PVP Principal Display Panel
- 4130 Kit Label SF00004222
- 4294 Kit Label SF00004164
-
INGREDIENTS AND APPEARANCE
4130 FIRST AID KIT
4130 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4130 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4130-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 30 mL Part 2 20 POUCH 6 mL Part 1 of 2 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 2 of 2 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 10/18/2018 4294 FIRST AID KIT
4294 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4294 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4294-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 30 mL Part 2 10 POUCH 3 mL Part 1 of 2 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 2 of 2 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 10/18/2018 Labeler - Honeywell Safety Products USA, INC (079287321) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, INC 079287321 pack(0498-4294, 0498-4130) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100) Establishment Name Address ID/FEI Business Operations Sion Medical Biotext 532775194 manufacture(0498-0121)