NDC | 0498-0100-01, 0498-0121-00, 0498-0143-04, 0498-3334-00, 0498-4226-01 |
Set ID | 84b4922c-71ea-45b5-e053-2991aa0a229f |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, INC |
Generic Name | |
Product Class | |
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
-
4226
68058008E Kit Contents
2 1X3 WOVEN SING 50/BOX
1 INSTANT COLD PACK 4" X 6"
1 ADHESIVE TAPE W/P 1/2"X 5 YD
CARTON DISP COOL JEL 1/8 OZ
1 CO-FLEX BANDAGE 2"X 5YDS TAN
4 PVP PREP PADS MEDIUM
1 1 OZ, BUFF EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 #10 KIT EMPTY NO LOGO (BLANK)
1 F. A. INST CHART SM (INDIVIDUAL LBL)
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
2 PR LRG NITRILE GLVES ZIP BAG
4 WIPE ALCOHOL PREP IPA 70% (DUKAL)
2 EYE PADS STD OVAL STERILE
5 GAUZE PADS 3"X3" 12PLY
1 ZIP-LOCK BAG 5" X 5" .002
2 AMMONIA INHALANT, BULK
- Alcohol Active ingredient
- Alcohol Purpose
- Alcohol Uses
- Alcohol Warnings
- Ammonia Inahalent Principal Display Panel
- Eyewash Principal Display Panel
- PVP Principal Display Panel
- 4226 Kit Label 68058008E
-
INGREDIENTS AND APPEARANCE
4226 FIRST AID KIT
4226 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4226 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4226-01 1 in 1 KIT; Type 0: Not a Combination Product 03/14/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 4 POUCH 1.6 mL Part 2 2 AMPULE 0.6 mL Part 3 1 BOTTLE 30 mL Part 4 40 POUCH 12 mL Part 1 of 4 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 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(0498-4226) 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)