NDC | 0498-0100-01, 0498-0114-01, 0498-0121-00, 0498-0203-00, 0498-3334-00, 0498-4224-01 |
Set ID | 84b2f5b1-ce89-b2a1-e053-2991aa0ac22b |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number |
- Active ingredient
- Purpose
- Uses
- Warnings
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or Comments
- 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
- PVP Active ingredient
- PVP Purpose
- PVP Uses
- PVP Warnings
- PVP Directioons
- PVP Other information
- PVP Inactive ingredients
- PVP Questions and Comments?
- Aspirin Active ingredient
- 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?
-
4224
35824CG Kit Contents
1 AMMONIA INHALANTS 10 PER
2 GAUZE BANDAGE, 4" X 6 YD
1 TOURNIQUET, 1 PER
1 WIRE SPLINT 1 PER
2 GAUZE COMPRESS, 1728 SQ IN 1
2 BUFFERED EYE WASH 1 OZ BTL
2 ADHESIVE BDG,PLSTIC,1"X3"16PER
2 BURN JEL 1/8 OZ, 6 PER
1 PVP IODINE WIPES 10 PER
2 BANDAGE COMP 2" W/TELFA PAD 4
3 BANDAGE COMP 4" W/TELFA PAD 1
LBL STOCK 6-3/8"X4"
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 3"x1-7/8"
4 BAYER 12 PACK PER ZIP BAG
24 UNIT PLASTIC HIPS MT BLANK
1 ADHES TAPE EYE STRIPS 2'S
2 TRI BNDG NON WOVEN 40"X40"X56"
- Principal Display Panel
- Burn Jel Principal Display Panel
- PVP Principal Display Panel
- Aspirin Principal Display Panel
- 4224 Kit Label 35824CG
-
INGREDIENTS AND APPEARANCE
4224 FIRST AID KIT
4224 first aid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4224 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4224-01 1 in 1 KIT 09/13/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 24 PACKET 48 Part 2 10 AMPULE 3 mL Part 3 12 PACKET 42 g Part 4 10 POUCH 3 mL Part 5 2 BOTTLE 60 mL Part 1 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) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MINERAL OIL (UNII: T5L8T28FGP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) 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 2 of 5 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 3 of 5 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 4 of 5 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 NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) 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 5 of 5 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 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 James Alexander 040756421 manufacture(0498-3334) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc 079287321 pack(0498-4224) 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(0498-0203) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100) Establishment Name Address ID/FEI Business Operations Sion Biotext Medical 532775194 manufacture(0498-0121)