NDC | 0498-0100-01, 0498-0121-00, 0498-0203-00, 0498-0501-00, 0498-0733-00, 0498-0800-34, 0498-4157-01 |
Set ID | 87ede98f-a63d-ed5e-e053-2995a90a1abf |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, Inc. |
Generic Name | |
Product Class | |
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
- Sting Relief Active ingredient (in each wipe)
- Sting Relief Purposse
- Sting Relief Uses
- Sting Relief Warnings
- Sting Relief Directions
- Sting Relief Inactive ingredients
- Sting Relief Questions or Comments?
- Eyewash Active ingredient
- Eyewassh 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.
- Eyeash Directions
- Eyewash Inactive ingredients
- Eyeash Questions
- Hydrocortisone Active ingredient (in each gram)
- Hydrcortisone Purpose
- Hydrocortisone Uses
-
Hydrocortisone
Warnings
For external use onlyWhen using the product
- avoid contact with eyes
- do not begin use of any other hydrocortisone product unless you have consulted a doctor
- do not use for the treatment of diaper rash
- Hydrocortisone Directions
- Hydrocortisone Other information
- Hydrocortisone Inactive ingredients
- Hydrocortisone Questions or Comments?
- PVP Active ingredient
- PVP Purpose
- PVP Uses
- PVP Warnings
- PVP Directions
- PVP Other information
- PVP Inactive ingredients
- BZK Active ingredient
- BZK Purpose
- BZK Uses
-
BZK
Warnings
For external use only
Do not use
- in the eyes or over large areas of the body
- on mucous membranes
- on irritated skin
- in case of deep puncture wounds, animal bites or serious burns, consult a doctor
- longer than 1 week unless directed by a doctor
- BZK Directions
- BZK Other information
- BZK Inactive ingredient
-
4157
SF00002397 Kit Contents
1 TRIANGULAR BDG, NON-STERILE
1 WIRE SPLINT 1 PER
1 BANDAGE COMP, 2" OFFSET, 4 PER
1 BANDAGE COMP, 4" OFFSET, 1 PER
1 ADHESIVE BDG,PLSTIC,1"X3"16PER
1 1 OZ EYE WASH W/PADS & STRIPS
1 BURN JEL 1/8 OZ, 6 PER
1 HYDROCORTISON,1.O%,1/32 OZ,10P
2 PVP IODINE WIPES 10 PER
1 BIOHAZARD BAG/SCRAPER BBP
1 ANTIMCRBL ANTSPTC TWLETTS 6PER
1 NITRILE GLOVES 2PR BBP
1 CPR MICROSHIELD DOUBLE UNIT
LBL STOCK 6-3/8"X4"
1 LBL STOCK 3"x1-7/8"
1 KIT STL 16 UN (HORIZONTAL)
1 STING Relief WIPES 10
- Burn Jel Principal Display Panel
- Sting Relief Principal Display Panel
- Eyewash Principal Display Panel
- Hydrocortisone Principal Display Panel
- PVP Principal Display Panel
- BZK Principal Display Panel
- 4157 Kit Label SF-00002397
-
INGREDIENTS AND APPEARANCE
4157 FIRST AID KIT
4157 first aid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4157 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4157-01 1 in 1 KIT 09/13/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 PACKET 21 g Part 2 1 BOTTLE 30 mL Part 3 10 POUCH 4 mL Part 4 10 PACKET 9 g Part 5 20 POUCH 6 mL Part 6 6 PACKET 8.4 mL Part 7 10 PACKET 9 g Part 1 of 7 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 7 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, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) SODIUM CHLORIDE (UNII: 451W47IQ8X) 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 3 of 7 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 BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) 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 12/23/2017 Part 4 of 7 HYDROCORTISONE
anti-itch cream ointmentProduct Information Item Code (Source) NDC:0498-0800 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CETYL ALCOHOL (UNII: 936JST6JCN) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TROLAMINE (UNII: 9O3K93S3TK) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 not final part348 03/06/2013 10/15/2019 Part 5 of 7 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 WATER (UNII: 059QF0KO0R) NONOXYNOL-9 (UNII: 48Q180SH9T) 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 6 of 7 ANTISEPTIC TOWELETTE
benzalkonium chloride liquidProduct Information Item Code (Source) NDC:0498-0501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0501-00 1.4 mL 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 part333E 12/22/2017 Part 7 of 7 HYDROCORTISONE
anti-itch creamProduct Information Item Code (Source) NDC:0498-0801 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CETYL ALCOHOL (UNII: 936JST6JCN) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TROLAMINE (UNII: 9O3K93S3TK) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 not final part348 10/15/2019 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(0498-4157) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0203, 0498-0800, 0498-0801) 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(0498-0501) Establishment Name Address ID/FEI Business Operations Sion Medical Biotext 532775194 manufacture(0498-0121) Establishment Name Address ID/FEI Business Operations Safetec of America Inc 874965262 manufacture(0498-0733)