NDC | 0498-0031-40, 0498-0100-02, 0498-0114-01, 0498-0203-00, 0498-0501-00, 0498-3334-00, 0498-4142-01 |
Set ID | 88139e57-9aa7-c703-e053-2a95a90aa731 |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- Eyewash Active ingredient
- Eyewash 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.
- Eyewash Directions
- Eyewash Inactive ingredients
- Eyewash 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
- Ammonia Active ingredient
- Ammonia Purpose
- Ammonia Uses
- Ammonia Warnings
- Ammonia Directions
- Ammonia Other information
- Ammonia Inactive ingredient
- Ammonia Questions or Comments?
- Water Soluble 1st Aid Spray Active ingredient
- Water Soluble 1st Aid Spray Purpose
- Water Soluble 1st Aid Spray Uses
-
Water Soluble 1st Aid Spray
Warnings
For external use only
Flammable
- keep away from fire or flame
- contents under pressure
- do not puncture or incinerate container
- do not expose to temperature above 120 0 F
Do not use
- in the eyes or other mucous membranes
- in cases of serious burns
- in case of deep orpuncture wounds
- for a prolonged period of time
- on large portion of the body
- Water Soluble 1st Aid Spray Directions
- Water Soluble 1st Aid pray Other information
- Water Soluble 1st Aid pray Inactive ingredients
- 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
- BZK Active ingredient
- BZK Purpose
- BZK Uses
- BZK Warnings
- BZK Directions
- BZK Other information
- BZK Inactive ingredient
- BZK Questions
-
4142
SF00004067 Kit Contents
1 KNUCKLE BAND 8 PER
1 WIRE SPLINT 1 PER
1 GAUZE PADS, 3" X 3", 4 PER
1 INSTANT COLD PACK 4" X 6"
1 ADHESIVE BDG,PLSTIC,1"X3"16PER
1 FINGERTIP BANDAGE, 10 PER
1 BURN JEL 1/8 OZ, 6 PER
1 ANTIMCRBL ANTSPTC TWLETTS
1 FIRST AID GUIDE ASHI
1 TAPE ADHESIVE 1"X 5 YD PLSTC
2 GAUZE CLEAN-WRAP BDGE N/S 2"
1 FIRST AID SPRAY AEROSOL 3 OZ
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
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"
2 PR LRG NITRILE GLVES ZIP BAG
1 KIT STL 24 UN WHITE 01
1 TRI BNDG NON WOVEN 40"X40"X56"
10 NON ADHERENT PAD 2" X 3"
3 ASPIRIN BULK 2/PK
2 AMMONIA INHALANT, BULK
- Eyewash Principal Display Panel
- Aspirin Principal Display Panel
- Ammonia Principal Display Panel
- Water Soluble 1st Aid Spray Principal Display Panel
- Burn Jel Principal Display Panel
- BZK Principal Display Panel
- 4142 Kit Label SF00004067
-
INGREDIENTS AND APPEARANCE
4142 FIRST AID KIT
4142 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4142 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4142-01 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 21 g Part 2 1 BOTTLE 118 mL Part 3 3 PACKET 6 Part 4 2 AMPULE 0.6 mL Part 5 1 CAN 85 g Part 6 1 POUCH 1.4 mL Part 1 of 6 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 TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) DIPROPYLENE GLYCOL (UNII: E107L85C40) TEA TREE OIL (UNII: VIF565UC2G) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) METHYLPARABEN (UNII: A2I8C7HI9T) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE DISODIUM (UNII: 7FLD91C86K) 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 6 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, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0100-02 118 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 6 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 6 AMMONIA INHALENT
ammonia inhalent inhalantProduct Information Item Code (Source) NDC:0498-3334 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g in 0.3 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-3334-00 0.3 mL in 1 AMPULE; 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 5 of 6 FIRST AID ANTISEPTIC WATER SOLUBLE
benzethonium chloride, benzocaine sprayProduct Information Item Code (Source) NDC:0498-0031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g in 100 g BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 g in 100 g Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) DIPROPYLENE GLYCOL (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0031-40 85 g in 1 CAN; 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 09/19/2018 Part 6 of 6 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 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 part333E 12/21/2017 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 James Alexander 040756421 manufacture(0498-3334) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, INC 079287321 pack(0498-4142) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 manufacture(0498-0114) Establishment Name Address ID/FEI Business Operations Dixon Investments 115315822 manufacture(0498-0031) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0203) Establishment Name Address ID/FEI Business Operations Changzhou Maokang Medical 421317073 manufacture(0498-0100) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0501)