NDC | 0498-0121-00, 0498-0203-00, 0498-3334-00, 0498-4192-01 |
Set ID | 83ad7c3e-775d-c060-e053-2991aa0a500c |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number |
- Active ingredient
- Purpose
- Uses
- Warnings
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or Comments
- Burn Jel Active ingredient
- Burn Jel Purpose
- Burn Jel Uses
- Burn Jel Warnings
- Burn JEl Directions
- Burn Jel Other information
- Burn Jel Inactive ingredients
- Burn Jel Questions
-
4192
011077-4258 Kit Contents
1 KNUCKLE BAND 8 PER
2 AMMONIA INHALANTS 10 PER
1 EYE DRESS PKT W/4 ADH STRIPS
2 GAUZE BANDAGE, 4" X 6 YD
2 TRIANGULAR BDG, NON-STERILE
2 GAUZE PADS, 3" X 3", 4 PER
1 ADH TAPE, .5" X 2.5 YD, 2 PER
1 INSTANT COLD PACK 4" X 6"
2 BANDAGE COMP, 2" OFFSET, 4 PER
2 BANDAGE COMP, 4" OFFSET, 1 PER
2 BURN JEL 1/8 OZ, 6 PER
3 PVP IODINE WIPES 10 PER
3 ADH BDG, CLOTH, 1"X3", 16 PER
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 KIT STL 24 UN WHITE 01
1 LABL INSTR 24 & 36 UNIT KITS
- Principal Display Panel
- Burn Jel Principal Display Panel
- 4192 Kit Label 011077-4258
-
INGREDIENTS AND APPEARANCE
4192 FIRST AID KIT
4192 first aid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4192 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4192-01 1 in 1 KIT 09/13/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 20 AMPULE 6 mL Part 2 12 PACKET 42 g Part 3 30 POUCH 9 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 BURN JEL
gel for burns gelProduct Information Item Code (Source) NDC:0498-0203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2 g in 100 g Inactive Ingredients Ingredient Name Strength TEA TREE OIL (UNII: VIF565UC2G) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) PROPYLPARABEN (UNII: Z8IX2SC1OH) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) DIPROPYLENE GLYCOL (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0203-00 3.5 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 part348 09/19/2018 Part 3 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/13/2018 Labeler - Honeywell Safety Products USA, Inc. (079287321) Registrant - 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(0498-4192) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0203) Establishment Name Address ID/FEI Business Operations Sion Biotext Medical 532775194 manufacture(0498-0121)