NDC | 0498-0501-00, 0498-0800-35, 0498-0903-34, 0498-4223-01, 0498-4275-01 |
Set ID | 84b217c0-2086-1d85-e053-2a91aa0a4afc |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, INC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number |
- First Aid Burn Cream Active ingredient
- First Aid Burn Cream Purpose
- First Aid Burn Cream Uses
- First Aid Burn Cream Warnings
- First Aid Burn Cream Directions
- First Aid Burn Cream Other information
- First Aid Burn Cream Inactive ingredients
- First Aid Burn Cream Questions
- BZK Wipes Active ingredient
- BZK Wipes 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 Inactive ingredient
- BZK Questions
- Hydrocortisone Active ingredient (in each gram)
- Hydrocortisone Purpose
- Hydrocortisone Uses
- Hydrocortisone Warnings
- Hydrocortisone Directions
- Hydrocortisone Other information
- Hydrocortisone Inactive ingredients
- Hydrocortisone Questions or Comments?
-
4275
SF00001582 kit contents
1 ADH TAPE W/P 1/2"X 2 1/2 YD
1 GAUZE CLEAN-WRAP BDGE N/S 2"
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 600H EMPTY BOX BLANK
1 F. A. INST CHART SM (INDIVIDUAL LBL)
LBL STOCK 6-3/8"X4"
1 LBL STOCK 3"x1-7/8"
4 BZK ANTISEPTIC WIPE, BULK
4 FIRST AID CREAM 1.0GR PKT EACH
4 HYDROCORTISONE 1% 0.9GM
4 GAUZE PADS 2"X2" 12PLY
2 EYE PADS STD OVAL STERILE
4 NON ADHERENT PAD 2" X 3"
- First Aid Burn Cream Principal Display Panel
- BZK Principal Display Panel
- Hydrocortisone Principal Display Panel
- 4223 Kit Label 34575H
- 4275 Kit Label SF00001582
-
INGREDIENTS AND APPEARANCE
4223 FIRST AID KIT
4223 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4223 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4223-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 4 PACKET 3.6 g Part 2 4 PACKET 3.6 g Part 3 4 PACKET 5.6 mL Part 4 4 PACKET 3.6 g Part 1 of 4 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 WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLPARABEN (UNII: Z8IX2SC1OH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) LIGHT MINERAL OIL (UNII: N6K5787QVP) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0801-35 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 not final part348 10/15/2019 Part 2 of 4 FIRST AID BURN
benzalkonium chloride, lidocaine hydrochloride creamProduct Information Item Code (Source) NDC:0498-0903 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) METHYLPARABEN (UNII: A2I8C7HI9T) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) LIGHT MINERAL OIL (UNII: N6K5787QVP) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0903-34 10 in 1 BOTTLE, UNIT-DOSE 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 part333A 12/20/2017 Part 3 of 4 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 12/21/2017 Part 4 of 4 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 WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLPARABEN (UNII: Z8IX2SC1OH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) LIGHT MINERAL OIL (UNII: N6K5787QVP) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0800-35 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 not final part348 03/06/2013 10/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4275 FIRST AID KIT
4275 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4275 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4275-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 4 PACKET 3.6 g Part 2 4 PACKET 3.6 g Part 3 4 PACKET 5.6 mL Part 4 4 PACKET 3.6 g Part 1 of 4 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 CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLPARABEN (UNII: Z8IX2SC1OH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) LIGHT MINERAL OIL (UNII: N6K5787QVP) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0801-35 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 not final part348 10/15/2019 Part 2 of 4 FIRST AID BURN
benzalkonium chloride, lidocaine hydrochloride creamProduct Information Item Code (Source) NDC:0498-0903 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) METHYLPARABEN (UNII: A2I8C7HI9T) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) LIGHT MINERAL OIL (UNII: N6K5787QVP) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 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 part333A 12/20/2017 Part 3 of 4 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 12/21/2017 Part 4 of 4 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 WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLPARABEN (UNII: Z8IX2SC1OH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) LIGHT MINERAL OIL (UNII: N6K5787QVP) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0800-35 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 not final part348 03/06/2013 10/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 Labeler - Honeywell Safety Products USA, INC (079287321) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, INC 079287321 pack(0498-4223, 0498-4275) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0903, 0498-0800, 0498-0801) Establishment Name Address ID/FEI Business Operations Changzhou Maokang Medical 421317073 manufacture(0498-0501)