Label: ARC FIRST AID CONTAINS 101 PIECES HARDCASE- benzalkonium chloride, lidocaine, water, isopropyl alcohol, aspirin kit
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Contains inactivated NDC Code(s)
NDC Code(s): 52124-0001-1, 52124-0002-1, 52124-0004-1, 52124-0005-1, view more52124-0012-1, 52164-1103-1 - Packager: American Red Cross
- Category: HUMAN OTC DRUG LABEL
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 June 7, 2010
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- 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
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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
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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
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PRINCIPAL DISPLAY PANEL
American Red Cross
Carrying Case
1 Soft-side Bag
1 Easy Access Pocket System
Small Cuts and Burns
25 Adhesive Plastic Bandages 3/4"x3"
25 Junior Plastic Bandages 3/8"x1-1/2"
1 Adhesive Plastic Bandage 1"x3"
1 Adhesive Spot Bandage 7/8"x7/8"
1 Elbow/Knee Adhesive Bandage
1 Burn Cream
20 Cotton Tipped Applicators
Medium Cuts and Scratches
1 Antiseptic Towelettes
1 Sterile Gauge Pad 2"x2"
1 Roller Gauge Bandage 2"x4.1yds.
1 Sterile Eye Pad
1 Sterile Eye Wash 10ml
2 Butterfly Wound Closure
Severe Bleeding and Burns
1 First Aid Tape Roll 1/2"x2.5 yds.
1 Combine Pad 5"x9"
1 Roller Gauge Bandage 3"x4.1yds
CPR
1 CPR Breathing Barrier
Protection
2 Medical Grade Vinyl Gloves
1 Alcohol Cleansing Pad
2 Chewable Aspirin Tablets
1 Triangular Bandage 42"x42"x59"
Instruments
1 Emergency First Aid Guide
6 Assorted Safety Pins
1 Plastic TweezersVisit RedCross.org for information on training in First Aid, CPR, AED and more
Manufactured in China for:
Genuine First Aid LLC.
600 Cleveland Street
Suite 400
Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AIDCopyright c 2009 Genuine First Aid LLC. All rights reserved.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARC FIRST AID CONTAINS 101 PIECES HARDCASE
benzalkonium chloride, lidocaine, water, isopropyl alcohol, aspirin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52164-1103 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52164-1103-1 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKAGE 0.9 g Part 2 1 PACKAGE 0.8 mL Part 3 1 BOTTLE 10 mL Part 4 1 PACKAGE 0.5 mL Part 5 1 PACKAGE 2 Part 1 of 5 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 5 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 5 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 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 final part333 04/28/2010 Part 5 of 5 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 04/28/2010 Labeler - American Red Cross (003255213) Establishment Name Address ID/FEI Business Operations GFA Production ( Xiamen) Co., Ltd 421256261 manufacture