NDC | 52124-0001-1, 52124-0002-1, 52124-0003-1, 52124-0004-1, 52124-0005-1, 52124-0008-1, 52124-0012-1, 52124-0106-1 |
Set ID | 7ec19862-e313-4071-9d07-49bb62ee482c |
Category | HUMAN OTC DRUG LABEL |
Packager | Genuine First Aid LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic |
Product Number | |
Application Number | PART333 |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- 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
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- WARNINGS
- DOSAGE & ADMINISTRATION
- PURPOSE
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- 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
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- DO NOT USE
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
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.
Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product. - DO NOT USE
-
ASK DOCTOR
Ask a doctor before use if you have;
asthma
stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems
a child experiencing arthritis pain
if you are;
allergic to aspirin
taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis - STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
CLINICAL PHARMACOLOGY
CARRYING CASE
1 Hard Case
1 Easy Access Pocket SystemPOCKET 1: SMALL CUTS AND BURNS
25 Adhesive Plastic Bandages 3/4"x3"
155 Junior Plastic Bandages 3/8"x1-1/2"
3 Adhesive Plastic Bandages 1"x3"
1 Knuckle Fabric Bandage
50 Adhesive Spot Bandages 7/8"x7/8"
1 Fingertip Fabric Bandage
1 Elbow/Knee Adhesive Bandage
1 Burn Cream
4 Antiseptic Towelettes
1 Triple Antibiotic Ointment 0.5gr
1 Sterile Gauge Pads 2"x2"
10 Cotton Tipped ApplicatorsPOCKET 2: MEDIUM CUTS AND SCRATCHES
4 Antiseptic Towelettes
1 Sterile Gauze Pad 2"x2"
1 Pressure Bandage 2"X2"
1 Pressure Bandage 3"X3"
1 Sterile Eye Pads
1 Sterile Eye Wash 10ml
2 Butterfly Wound ClosuresPOCKET 3: SEVERE BLEEDING AND BURNS
1 First Aid Tape Roll 1/2"x2.5 yds.
1 Bloodstopper DressingPOCKET:
CPR
1 CPR Breathing BarrierPOCKET 5:
PROTECTION
2 Medical Grade Gloves
1 Instant Cold Compress
5 Alcohol Cleansing Pads
1 Insect Sting Relief Pads
1 Emergency Blanket 38"x60"
2 Chewable Aspirin Tablets
1 Triangular Bandage 42"x42"x59"POCKET6:
INSTRUMENTS
1 Emergency First Aid Guide
1 Plastic Tweezers
1 Scissors
6 Assorted Safety Pins
2 Wooden Finger SplintsManufactured in China for:
Genuine First Aid LLC.
600 Cleveland Street
Suite 400
Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AIDCopyright C 2010 Genuine First Aid LLC. All rights reserved.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FIRST AID CONTAINS 303 PIECES HARDCASE
benzalkonium chloride, lidocaine, water, isotropyl alcohol, benzocaine, alcohol, aspirin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0106 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0106-1 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKAGE 0.9 g Part 2 8 PACKAGE 6.4 mL Part 3 1 BOTTLE 10 mL Part 4 5 PACKAGE 2.5 mL Part 5 1 PACKAGE 0.5 mL Part 6 1 PACKAGE 2 Part 7 1 TUBE 0.5 g Part 1 of 7 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0004-1 0.9 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part345 04/28/2010 Part 2 of 7 ANTISEPTIC TOWELETTE
benzalkonium chloride liquidProduct 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 part333 04/28/2010 Part 3 of 7 STERILE ISOTONIC BUFFERED GENUINE EYEWASH
water liquidProduct Information Item Code (Source) NDC:52124-0005 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.16 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0005-1 10 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 04/28/2010 Part 4 of 7 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 final part333 04/28/2010 Part 5 of 7 INSECT STING RELIEF PAD
benzocaine,alcohol liquidProduct 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 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 04/28/2010 Part 6 of 7 CHEWABLE ASPIRIN
aspirin tablet, chewableProduct Information Item Code (Source) NDC:52124-0012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SACCHARIN (UNII: FST467XS7D) SODIUM CATION (UNII: LYR4M0NH37) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) Product Characteristics Color orange (ORANGE) Score no score Shape ROUND Size 11mm Flavor Imprint Code ASPIRIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0012-1 2 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part345 04/28/2010 Part 7 of 7 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 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 part333 04/24/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 04/28/2010 Labeler - Genuine First Aid LLC (619609857) Establishment Name Address ID/FEI Business Operations GFA Production ( Xiamen) Co., Ltd 421256261 manufacture