Label: MEDIUM CUTS AND SCRATCHES- benzalkonium chloride, water kit
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Contains inactivated NDC Code(s)
NDC Code(s): 52124-0001-1, 52124-0005-1, 52124-0117-1 - Packager: Genuine First Aid LLC
- 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 June 7, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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
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PRINCIPAL DISPLAY PANEL
Medium Cuts, Burns and Severe Bleeding
5 Antiseptic Towelette
2 Sterile Gauge Pad 2"x2"
2 Sterile Gauge Pad 3"x3"
2 Sterile Gauge Pad 4"x4"
1 Roller Gauge Bandage 2"x4.1 yds.
1 Sterile Eye Pad
1 Sterile Eye Wash 10ml
2 Butterfly Wound ClosuresManufactured in China for:
Genuine First Aid LLC.
600 Cleveland Street
Suite 400
Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AIDCopyright 2009 Genuine First Aid LLC. All rights reserved.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEDIUM CUTS AND SCRATCHES
benzalkonium chloride, water kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0117 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0117-1 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 5 PACKAGE 4 mL Part 2 1 BOTTLE 10 mL Part 1 of 2 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 04/23/2010 Part 2 of 2 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 part345 04/23/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 04/23/2010 Labeler - Genuine First Aid LLC (619609857) Establishment Name Address ID/FEI Business Operations GFA Production ( Xiamen) Co., Ltd 421256261 manufacture