NDC | 47682-175-46, 52124-0001-1, 52124-0002-1, 52124-0003-1, 52124-0009-1, 52124-1200-1 |
Set ID | 56269be0-68c6-41da-a43d-da4db593db0a |
Category | HUMAN OTC DRUG LABEL |
Packager | Genuine First Aid, LLC |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333E |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- STORAGE AND HANDLING
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- INACTIVE INGREDIENT
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 thinner (anticoagulant) or steroid drug, take other drugs containing 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 - DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
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 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; any new symptoms appear - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions:
do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.
Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.
Children under 12 years: Do not give to children under 12 years of age. - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
- DO NOT USE
- WHEN USING
- INACTIVE INGREDIENT
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GENUINE FIRST AID - HOME FIRST AID
benzalkonium chloride, ibuprofen, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, acetaminophen kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-1200 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-1200-1 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 0.5 g Part 2 1 PACKET 2 Part 3 1 PACKET 2 Part 4 2 PACKAGE 1.6 mL Part 5 2 PACKAGE 1 mL Part 1 of 5 GENUINE TRIPLE ANTIBIOTIC
bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointmentProduct Information Item Code (Source) NDC:52124-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 5000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0003-1 .5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 01/11/2011 Part 2 of 5 IBUPROFEN
ibuprofen tabletProduct Information Item Code (Source) NDC:52124-0009 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength POWDERED CELLULOSE (UNII: SMD1X3XO9M) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white (WHITE) Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;352 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0009-1 2 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075010 01/11/2011 Part 3 of 5 MEDIQUE APAP EXTRA STRENGTH
acetaminophen tablet, film coatedProduct Information Item Code (Source) NDC:47682-175 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 68401960MK) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white (WHITE) Score no score Shape ROUND Size 12mm Flavor Imprint Code AZ;235 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-175-46 2 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/11/2011 Part 4 of 5 ANTISEPTIC TOWELETTE
benzalkonium chloride swabProduct Information Item Code (Source) NDC:52124-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.40 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0001-1 0.8 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 01/11/2011 Part 5 of 5 ALCOHOL CLEANSING PAD
isopropyl alcohol liquidProduct Information Item Code (Source) NDC:52124-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0002-1 0.5 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/11/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/11/2011 Labeler - Genuine First Aid, LLC (619609857)