NDC | 0498-0114-01, 0498-0143-04, 0498-0733-00, 0498-3334-00, 0498-4225-01, 0498-4227-01, 0498-4228-01, 0498-4251-01 |
Set ID | 84b8cbcc-e5f0-d345-e053-2991aa0acaa0 |
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
- Alcohol Wipe Active ingredient
- Alcohol Wipe Purpose
- Alcohol Wipe Uses
- Alcohol Wipe Warnings
- Alcohol Wipe Directions
- Alcohol Wipe Other information
- Alcohol Wipe Inactive ingredient
- Alcohol Wipe 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
- Sting Relief Active ingredient (in each wipe)
- Sting Relief Purpose
- Sting Relief Uses
- Sting Relief Warnings
- Sting Relief Directions
- Sting Relief Inactive ingredients
- Sting Relief Questios or Comments?
- Ammonia Active ingredient
- Ammonia Purpose
- Ammonia Uses
- Ammonia Warnings
- Ammonia Directions
- Ammonia Other information
- Ammonia Inactive ingredients
- Ammonia Questions or Comments?
-
4225
662010P Kit Contents
1 INSTANT COLD PACK 4" X 6"
1 ADHESIVE BDG,PLSTIC,1"X3"16PER
1 ADH TAPE W/P 1/2"X 2 1/2 YD
1 GAUZE CLEAN-WRAP BDGE N/S 2"
1 1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 F. A. INST CHART SM (INDIVIDUAL LBL)
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 PR LRG NITRILE GLVES ZIP BAG
1 FIRST AID CREAM FOIL PKS 16/BG
1 12 ASPIRIN TABLETS (6 2/PKS)
3 WIPE ALCOHOL PREP IPA 70% (DUKAL)
1 KIT, PP 10 UNIT FA
2 ADHES TAPE EYE STRIPS 2'S
3 SAFETEC STING RELIEF WIPES BULK
1 TRI BNDG NON WOVEN 40"X40"X56"
2 EYE PADS STD OVAL STERILE
5 GAUZE PADS 4"X4" 12PLY
3 AMMONIA INHALANT, BULK
-
4227
6810BR Kit Contents
1 INSTANT COLD PACK 4" X 6"
1 ADH BDG,PLSTIC,3/4"X3",16 PER
1ADH TAPE W/P 1/2"X 2 1/2 YD
1 GAUZE CLEAN-WRAP BDGE N/S 2"
1 FIRST AID CREAM 0.9 GRM PKT 20
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 F. A. INST CHART SM (INDIVIDUAL LBL)
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 PR LRG NITRILE GLVES ZIP BAG
3 WIPE ALCOHOL PREP IPA 70% (DUKAL)
1 KIT STL 10 UN WHITE 01
2 ADHES TAPE EYE STRIPS 2'S
3 SAFETEC STING RELIEF WIPES BULK
1 TRI BNDG NON WOVEN 40"X40"X56"
2 EYE PADS STD OVAL STERILE
5 GAUZE PADS 4"X4" 12PLY
6 ASPIRIN BULK 2/PK
3 AMMONIA INHALANT, BULK
-
4228
6810PMD Kit Contents
1 INSTANT COLD PACK 4" X 6"
1 ADH BDG,PLSTIC,3/4"X3",16 PER
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 F. A. INST CHART SM (INDIVIDUAL LBL)
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 PR LRG NITRILE GLVES ZIP BAG
1 FIRST AID CREAM FOIL PKS 16/BG
12 ASPIRIN TABLETS (6 2/PKS)
3 WIPE ALCOHOL PREP IPA 70% (DUKAL)
1 KIT, PP 10 UNIT FA
2 ADHES TAPE EYE STRIPS 2'S
3 SAFETEC STING RELIEF WIPES BULK
1 TRI BNDG NON WOVEN 40"X40"X56"
2 EYE PADS STD OVAL STERILE
5 GAUZE PADS 4"X4" 12PLY
1 ZIP-LOCK BAG 5" X 5" .002
3 AMMONIA INHALANT, BULK
-
4251
68P10BR kit contents
1 INSTANT COLD PACK 4" X 6"
1 ADHESIVE BDG,PLSTIC,1"X3"16PER
1 ADH TAPE W/P 1/2"X 2 1/2 YD
1 GAUZE CLEAN-WRAP BDGE N/S 2"
1 FIRST AID CREAM 0.9 GRM PKT 20
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 F. A. INST CHART SM (INDIVIDUAL LBL)
LBL STOCK 6-3/8"X4"
LBL STOCK 4"X2-7/8"
1 LBL STOCK 3"x1-7/8"
1 PR LRG NITRILE GLVES ZIP BAG
3 WIPE ALCOHOL PREP IPA 70% (DUKAL)
1 KIT, PP 10 UNIT FA
1 SAFETEC STING RELIEF WIPES BULK
1 TRI BNDG NON WOVEN 40"X40"X56"
5 GAUZE PADS 3"X3" 12PLY
6 ASPIRIN BULK 2/PK
3 AMMONIA INHALANT, BULK
- First Aid Burn Cream Principal Display Panel
- Alcohol Wipe Label
- Aspirin Principal Display Panel
- Sting Relief Principal Display Panel
- Ammonia Principal Display Panel
- 4225 Kit Label 662010P
- 4227 Kit Label 6810BR
- 4228 Kit Label 6810PMD
- 4251 Kit Label 68P10BR
-
INGREDIENTS AND APPEARANCE
4227 FIRST AID KIT
4227 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4227 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4227-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 20 PACKET 18 g Part 2 3 POUCH 1.2 mL Part 3 6 PACKET 12 Part 4 3 POUCH 1.2 mL Part 5 3 AMPULE 0.9 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 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 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 STING RELIEF PAD
ethyl alcohol, lidocaine swabProduct Information Item Code (Source) NDC:0498-0733 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0733-00 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 part348 12/23/2017 Part 5 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4228 FIRST AID KIT
4228 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4228 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4228-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 PACKET 14.4 g Part 2 3 POUCH 1.2 mL Part 3 6 PACKET 12 Part 4 3 POUCH 1.2 mL Part 5 3 AMPULE 0.9 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 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 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 STING RELIEF PAD
ethyl alcohol, lidocaine swabProduct Information Item Code (Source) NDC:0498-0733 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0733-00 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 part348 12/23/2017 Part 5 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4225 FIRST AID KIT
4225 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4225 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4225-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 PACKET 14.4 g Part 2 3 POUCH 1.2 mL Part 3 6 PACKET 12 Part 4 3 POUCH 1.2 mL Part 5 3 AMPULE 0.9 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 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 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 STING RELIEF PAD
ethyl alcohol, lidocaine swabProduct Information Item Code (Source) NDC:0498-0733 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0733-00 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 part348 12/23/2017 Part 5 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4251 FIRST AID KIT
4251 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4251 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-4251-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 20 PACKET 18 g Part 2 3 POUCH 1.2 mL Part 3 6 PACKET 12 Part 4 1 POUCH 0.4 mL Part 5 3 AMPULE 0.9 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 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 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 STING RELIEF PAD
ethyl alcohol, lidocaine swabProduct Information Item Code (Source) NDC:0498-0733 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.5 mL in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0733-00 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 part348 12/23/2017 Part 5 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 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(0498-4225, 0498-4227, 0498-4228, 0498-4251) 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) Establishment Name Address ID/FEI Business Operations Changzhou Maokang Medical 421317073 manufacture(0498-0143) Establishment Name Address ID/FEI Business Operations Safetec of America Inc 874965262 manufacture(0498-0733)