Label: EASY CARE FIRST AID - ALL PURPOSE- benzalkonium chloride, benzocaine, sd alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, ibuprofen, acetaminophen kit
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Contains inactivated NDC Code(s)
NDC Code(s): 44224-1999-6, 52124-0001-1, 52124-0003-1, 52124-0004-1, view more52124-0008-1, 52124-0009-1, 52124-0010-1 - Packager: Tender Corp dba Adventure Medical Kits
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 15, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
- DO NOT USE
- Directions
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
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- STORAGE AND HANDLING
- DO NOT USE
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
- Warnings
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- STORAGE AND HANDLING
- Inactive Ingredient
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PRINCIPAL DISPLAY PANEL
Genuine Triple Antibiotic
First Aid Ointment
To Help Prevent Infection
Each Gram Contains:
Bacitracin Zinc 400 units
Neomycin Sulfate 5 mg
(equivalent to 3.5 mg
Neomycin base)
Polymyxin B Sulfate 5000 units
Net Wt. 0.5g ; (1/64 oz)
Manufactured in CHINA for
GENUINE FIRST AID.
Triple Antibiotic Ointment 10pcs
Net wt. 0.9g (1/32oz)
100
Triple Antibiotic
- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings:
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Adults and Children Take 2 tablets every 4 to 6 hours as
12 years of age needed. Do not take more than 12 tablets
or older in 24 hours.
Children 6-11 years Take 1 tablet every 4 to 6 hours as
of age needed. Do not take more than 5
tablets in 24 hours.
Children under 6 Do not use this regular strength product.
years of age This will provide more than the
recommended dose (overdose) and could
cause serious health problems.
- STORAGE AND HANDLING
- GENERAL PRECAUTIONS
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- PURPOSE
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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 Ingredients
- Purpose
- Uses
- Warnings
-
DO NOT USE
Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week
Do not use:
in the eyes or apply over large areas of the body.
longer than 1 week unless directed by a doctor.
in large quantities, particularly over raw surfaces or blistered areas.
Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.
When using this product, avoid contact with the eyes.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- STORAGE AND HANDLING
- Inactive Ingredients
- 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
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INGREDIENTS AND APPEARANCE
EASY CARE FIRST AID - ALL PURPOSE
benzalkonium chloride, benzocaine, sd alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, ibuprofen, acetaminophen kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44224-1999 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44224-1999-6 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 20 PACKAGE 16 mL Part 2 4 PACKAGE 2.0 mL Part 3 2 TUBE 1.0 g Part 4 4 PACKAGE 8 Part 5 4 PACKET 8 Part 6 2 PACKET 1.8 g Part 1 of 6 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 0.4 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 not final part333E 04/15/2011 Part 2 of 6 INSECT STING RELIEF PAD
benzocaine,alcohol swabProduct Information Item Code (Source) NDC:52124-0008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6 mL in 100 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 60 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:52124-0008-1 0.5 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 04/15/2011 Part 3 of 6 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 0.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 04/15/2011 Part 4 of 6 NON-ASPIRIN
acetaminophen tabletProduct Information Item Code (Source) NDC:52124-0010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color white (WHITE) Score no score Shape ROUND Size 11mm Flavor Imprint Code AZ;234 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0010-1 2 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/15/2011 Part 5 of 6 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 02/17/2010 Part 6 of 6 GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE
benzalkonium chloride, lidocaine creamProduct Information Item Code (Source) NDC:52124-0004 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 (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0004-1 0.9 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333A 04/15/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 04/15/2011 Labeler - Tender Corp dba Adventure Medical Kits (064437304)