NDC | 0498-0114-01, 0498-0143-04, 0498-0501-00, 0498-0750-35, 0498-4250-01 |
Set ID | 85f7fae3-78fd-6ac7-e053-2991aa0a941b |
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 |
- 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
- Triple Active ingredient (each gram contains)
- Triple Purpose
- Triple Uses
- Triple Warnings
- Triple Directions
- Triple Other information
- Triple Inactive ingredient
- Triple Questions
- Aspirin Active ingredient (in each tablet)
- Aspirin Purpose
- Aspirin Uses
-
Aspirin
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are:
- age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout or arthritis
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- ringing in the ears or loss of hearing occurs
- any new symptoms appear
If pregnant or breast-feeding,
If pregnant or breat-feeding, ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Aspirin Directions
- Aspirin Other information
- Aspirin Inactive ingredients
- Aspirin Questions or Comments
- BZK Active ingredient
- BZK Purpose
- BZK Uses
-
BZK
Warnings
For external use onlyDo 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 ingredients
- BZK Questions
- Alcohol Wipe Active ingredient
- Alcohol Wipe Purpose
- Alcohol Wipe Uses
- Alcohol Wipes Warnings
- Alcohol Wipe Directions
- Alcohol Wipe Other information
- Alcohol Wipe Inactive ingredient
- Alcohol Wipe Questions
-
4250
68P10SCHW Kit Contents
1 INSTANT COLD PACK 4" X 6"
1 ADH BDG,PLSTIC,3/4"X3",16 PER
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
1 TAPE ADHESIVE 1"X 5 YD PLSTC
1 GAUZE CLEAN-WRAP BDGE N/S 2"
1 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 SCISSOR BDGE 4" RED PLS HDL
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
6 BZK ANTISEPTIC WIPE, BULK
2 PR LRG NITRILE GLVES ZIP BAG
6 FIRST AID CREAM 1.0GR PKT EACH
3 TRIPLE BIOTIC FOIL PACK EACH
6 WIPE ALCOHOL PREP IPA 70% (DUKAL)
1 KIT, PP 10 UNIT FA
1 TRI BNDG NON WOVEN 40"X40"X56"
4 GAUZE PADS 2"X2" 12PLY
1 EYE PADS STD OVAL STERILE
4 GAUZE PADS 3"X3" 12PLY
2 GAUZE PADS 4"X4" 12PLY
1 WOVEN FINGERTIP BANDAGE 2"
1 HEAVY FLEX LARGE PATCH 2" X 3"
3 ASPIRIN BULK 2/PK
- First Aid Burn Cream Principal Display Panel
- Triple Principal Display Panel
- Aspirin Principal Display Panel
- BZK Principal Display Panel
- Alcohol Wipe Principal Display Panel
- 4250 Kit Label 68FP10SCHW
-
INGREDIENTS AND APPEARANCE
4250 FIRST AID KIT
4250 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4250 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4250-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 PACKET 5.4 g Part 2 6 PACKET 8.4 mL Part 3 3 PACKET 6 Part 4 3 PACKET 2.7 g Part 5 6 POUCH 2.4 mL Part 1 of 5 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 2 of 5 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 09/18/2018 Part 3 of 5 ASPIRIN
aspirin tabletProduct Information Item Code (Source) NDC:0498-0114 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MINERAL OIL (UNII: T5L8T28FGP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code FR21 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0114-01 2 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 part343 09/18/2018 Part 4 of 5 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 BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [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 Part 5 of 5 ALCOHOL WIPE
isopropyl alcohol swabProduct Information Item Code (Source) NDC:0498-0143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0143-04 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 part333A 09/18/2018 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(0498-4250) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 manufacture(0498-0114) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0903, 0498-0750) Establishment Name Address ID/FEI Business Operations Changzhou Maokang Medical 421317073 manufacture(0498-0501, 0498-0143)