NDC | 0498-0121-00, 0498-0203-00, 0498-0750-35, 0498-4276-01 |
Set ID | 86ad36a5-08dc-7792-e053-2a91aa0a2f6b |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic |
Product Number | |
Application Number |
- 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
- Triple Active ingredient
- Triple Purpose
- Triple Uses
-
Triple
Warnings
For external use only
Allergy alert: do not use if you are allergic to any of the ingredients
Do not use
- in the eyes
- over large areas of the body
- Ask a doctor before use if you have
- a deep or puncture wounds
- animal bites
- serious burns
- Triple Directions
- Triple Other information
- Triple Inactive ingredient
- Triple Questions?
- PVP Wipe Active ingredient
- PVP Wipe Purpose
- PVP Wipe Uses
- PVP Wipe Warnings
- PVP Wipe Directions
- PVP Wipes Other information
- PVP Wipes Inactive ingredients
- PVP Wipes Questions
-
4276
SF00001585 Kit Contents
1 TRIPLE ANTIBIOTIC 10 PER
1 TRIANGULAR BDG, NON-STERILE
1 GAUZE PADS, 3" X 3", 4 PER
1 INSTANT COLD PACK 4" X 6"
1 ADHESIVE BDG,PLSTIC,1"X3"16PER
1 BURN JEL 1/8 OZ, 6 PER
1 PVP IODINE WIPES 10 PER
1 NITRILE GLOVES 2PR BBP
1 TWEEZER PLASTICS 4"
FLEXICON 3"X 4.1 YD 12/BAG
1 FIRST AID GUIDE ASHI
1 SCISSOR BDGE 4" RED PLS HDL
1 BANDAGE COMP 4" W/TELFA PAD 1
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 KIT, PP 16 UNIT FA
2 ADHES TAPE EYE STRIPS 2'S
2 EYE PADS STD OVAL STERILE
- Burn Jel Principal Display Panel
- Triple Principal Display Panel
- PVP Wipe Principal Display Panel
- 4276 Kit Label SF00001585
-
INGREDIENTS AND APPEARANCE
4276 FIRST AID KIT
4276 first aid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4276 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4276-01 1 in 1 KIT 09/13/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 PACKET 21 g Part 2 10 POUCH 3 mL Part 3 5 PACKET 4.4 g Part 1 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 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 TRIPLE ANTIBIOTIC
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointmentProduct Information Item Code (Source) NDC:0498-0750 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0750-35 0.9 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 final part333B 09/19/2018 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 Honeywell Safety Products USA, Inc 079287321 pack(0498-4276) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0203, 0498-0750) Establishment Name Address ID/FEI Business Operations Sion Medical Biotext 532775194 pack(0498-0121)