NDC | 0498-0202-00, 0498-4007-01, 0498-4013-01 |
Set ID | 865cd040-22d1-ed63-e053-2991aa0aa9b9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number |
- Burn Jel Active ingredient
- Burn Jel Purpose
- Burn Jel Uses
- Burn Jel Warnings
- Burn Jel Keep out of reach of children
- Burn Jel Directions
- Burn Jel Other information
- Burn Jel Inactive ingredients
- Burn Jel Questions
- Paws Active ingredient
- Paws Purpose
- Paws Uses
- Paws Warnings
- Paws Directions
- Paws Inactive ingredients
- Paws Questions
-
4007
34TP165 Kit Contents
1 1 X 3 PLASTIC 50/BOX
1 GAUZE BANDAGE, 4" X 6 YD
1 TRIANGULAR BDG, NON-STERILE
1 INSTANT COLD PACK 4" X 6"
1 BURN JEL 1/8 OZ, 6 PER
1 ADHESIVE TAPE W/P 1/2"X 5 YD
1 GAUZE CLEAN-WRAP BDGE N/S 2"
1 ABD COMBINE PAD 5" X 9"
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 F. A. INST CHART SM (INDIVIDUAL LBL)
1 CPR KIT-MASK, GLOVES, WIPES
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 BODY FLUID CLEAN UP KIT BAG
1 KIT PP 24 UNIT FA
-
4013
34T150 kit contents
1 1 X 3 PLASTIC 50/BOX
1 GAUZE BANDAGE, 4" X 6 YD
1 TRIANGULAR BDG, NON-STERILE
1 INSTANT COLD PACK 4" X 6"
1 BURN JEL 1/8 OZ, 6 PER
1 ADHESIVE TAPE W/P 1/2"X 5 YD
1 GAUZE CLEAN-WRAP BDGE N/S 2"
1 ABD COMBINE PAD 5" X 9"
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 F. A. INST CHART SM (INDIVIDUAL LBL)
1 CPR KIT-MASK, GLOVES, WIPES
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 BODY FLUID CLEAN UP KIT BAG
1 KIT STL BULK MEDIUM
- Burn Jel Principal Display Panel
- Paws Principal Display Panel
- 4007 Kit Label 34TP165
- 4013 Kit Label 34T150
-
INGREDIENTS AND APPEARANCE
4007 FIRST AID KIT
4007 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4007 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4007-01 1 in 1 KIT 09/12/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 PACKET 21 mL Part 2 2 PACKET 0.0038 L Part 1 of 2 BURN JEL
gel for burns gelProduct Information Item Code (Source) NDC:0498-0202 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 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERIN (UNII: PDC6A3C0OX) TEA TREE OIL (UNII: VIF565UC2G) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) OCTOXYNOL 9 (UNII: 7JPC6Y25QS) DIPROPYLENE GLYCOL (UNII: E107L85C40) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0202-00 3.5 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 part348 12/08/2017 Part 2 of 2 PAWS
ethyl alcohol liquidProduct Information Item Code (Source) NDC:0498-3111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 665 mL in 1 L Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.0019 L 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/12/2018 4013 FIRST AID KIT
4013 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4013 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4013-01 1 in 1 KIT 09/12/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 PACKET 21 mL Part 2 2 PACKET 0.0038 L Part 1 of 2 BURN JEL
gel for burns gelProduct Information Item Code (Source) NDC:0498-0202 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 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERIN (UNII: PDC6A3C0OX) TEA TREE OIL (UNII: VIF565UC2G) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) OCTOXYNOL 9 (UNII: 7JPC6Y25QS) DIPROPYLENE GLYCOL (UNII: E107L85C40) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0202-00 3.5 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 part348 12/08/2017 Part 2 of 2 PAWS
ethyl alcohol liquidProduct Information Item Code (Source) NDC:0498-3111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 665 mL in 1 L Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.0019 L 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/12/2018 Labeler - Honeywell Safety Products USA, Inc. (079287321) Registrant - Honeywell Safety Products US, Inc. (079287321) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc 079287321 pack(0498-4007, 0498-4013)