NDC | 0498-0121-00, 0498-0733-00, 0498-3334-00, 0498-4270-01 |
Set ID | 86699708-ed56-7c71-e053-2991aa0a2c72 |
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
- 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
- Sting Relief Active ingredient (in each wipe)
- Sting Relief Purpose
- Sting Relief Uses
- Sting Relief Warnings
- Stig Relief Directions
- Sting Relief Inactive ingredients
- Questions or Comments?
-
4270
SF00001090 Kit Contents
1 1 X 3 PLASTIC 50/BOX
1 WOVEN 2" X 3" 25/BOX
1 KNUCKLE BAND 8 PER
1 AMMONIA INHALANTS 10 PER
1 EYE DRESS PKT W/4 ADH STRIPS
2 INSTANT COLD PACK 4" X 6"
1 FINGERTIP BANDAGE, 10 PER
1 PVP IODINE WIPES 10 PER
2 ADHES TAPE W/P 1"X 2 1/2 YD
2 GAUZE BANDAGE 2"X2 YDS STRETCH GZ
1 FIRST AID GUIDE ASHI
1 GZE PADS STERILE 3"X 3" 10'S
1 CPR FILTERSHIELD 77-100
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 180 EMPTY BLANK NO LOGO
1 POCKET INSERT RED #180 KIT 4R
2 BANDAGE COMP 4" W/TELFA PAD 1
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
3 PR LRG NITRILE GLVES ZIP BAG
1 WATER-JEL BURN DRESSING 4 X 4
1 NOX A STING WIPES 10
-
4401
SF00001103 kit contents
1 1 X 3 PLASTIC 50/BOX
1 WOVEN 2" X 3" 25/BOX
1 KNUCKLE BAND 8 PER
1 AMMONIA INHALANTS 10 PER
1 EYE DRESS PKT W/4 ADH STRIPS
2 INSTANT COLD PACK 4" X 6"
1 FINGERTIP BANDAGE, 10 PER
1 PVP IODINE WIPES 10 PER
2 ADHES TAPE W/P 1"X 2 1/2 YD
2 GAUZE BANDAGE 2"X2 YDS STRETCH GZ
1 FIRST AID GUIDE ASHI
1 GZE PADS STERILE 3"X 3" 10'S
1 CPR FILTERSHIELD 77-100
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
2 BANDAGE COMP 4" W/TELFA PAD 1
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
3 PR LRG NITRILE GLVES ZIP BAG
1 WATER-JEL BURN DRESSING 4 X 4
1 POLYBAG 14" X 20" '3 MIL'
1 STING relief WIPES 10
- Ammonia Inahalent Principal Display Panel
- PVP Principal Display Panel
- Sting Relief Principal Display Panel
- 4270 Kit Label SF00001090
- 4401 Kit Label SF00001103
-
INGREDIENTS AND APPEARANCE
4270 FIRST AID KIT
4270 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4270 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4270-01 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 10 POUCH 3 mL Part 3 10 POUCH 4 mL Part 1 of 3 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 3 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 3 of 3 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 MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 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 03/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/14/2019 4401 FIRST AID KIT
4401 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4401 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4401-01 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 10 POUCH 3 mL Part 3 10 POUCH 4 mL Part 1 of 3 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 3 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 3 of 3 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 MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 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 03/14/2019 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(0498-4270, 0498-4401) 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)