Label: FAK LARGE OFFICE FIRST AID KIT- benzalkonium chloride kit
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NDC Code(s):
50814-002-01,
50814-010-01,
50814-011-01,
50814-012-01, view more50814-013-01, 50814-014-01, 50814-015-01, 50814-031-01
- Packager: GFA Production (Xiamen) Co., Ltd.
- 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 October 19, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Antiseptic Towelettes - 113408 10 count (50814-011-01 ) DRUG FACTS
- Active Ingredient:
- Use:
- Warnings:
- Directions:
- Inactive ingredient:
- Antiseptic Towelette (50814-002-01) DRUG FACTS
- Active Ingredient:
- Use:
- Warnings:
- Directions:
- Inactive ingredient:
- Burn Treatment – 113402 10 count (50814-014-01) Drug Facts
- Active ingredients
- Uses
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Warnings
For external use only.
Do not use
• in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor
- Directions
- Other information
- Inactive ingredients
- Alcohol Cleansing Pads - 113409, 20 count (50814-012-01) DRUG FACTS
- Active Ingredient:
- Use:
- Warnings:
- Directions:
- Other information:
- Inactive ingredient:
- Antibiotic Application - 113401 10 count (50814-013-01) Drug Facts
- Active ingredients (in each gram)
- Use
-
Warnings
For external use only.
Do not use
• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.
- Directions
- Other information
- Inactive ingredients
- Hand Sanitizer – 117534 6 count (50814-015-01) Drug Facts
- Active ingredient
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Eyewash - 117445 30ml (50814-010-01) Drug Facts
- Active ingredient
- Use
-
Warnings
For external use only.
When using this product
• to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes
- Directions
- Other information
- Inactive ingredients
- Eyewash 30ml (70897-002-03) Drug Facts
- Active ingredient
- Use
-
Warnings
For external use only.
When using this product
• to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes
- Directions
- Other information
- Inactive ingredients
- Package Labeling:
- Antiseptic Towelettes
- Antiseptic Towelette
- Burn TreatmentÂ
- Alcohol Cleansing
- Antibiotic Application
- Hand Sanitizer
- Eyewash
- Eyewash2
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INGREDIENTS AND APPEARANCE
FAK LARGE OFFICE FIRST AID KITÂ
benzalkonium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50814-031 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50814-031-01 1 in 1 KIT 02/08/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PATCH 1.8 g Part 2 1 BAG 4.5 g Part 3 1 PACKAGE 0.9 g Part 4 1 PATCH 0.9 g Part 5 1 PACKAGE 0.9 g Part 6 1 PACKAGE 0.9 g Part 7 1 TUBE 30 mL Part 1 of 7 ANTISEPTIC TOWELETTESÂ
benzalkonium chloride clothProduct Information Item Code (Source) NDC:50814-011 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50814-011-01 10 in 1 BOX 1 1.8 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/08/2018 Part 2 of 7 ANTISEPTIC TOWELETTEÂ
benzalkonium chloride swabProduct Information Item Code (Source) NDC:50814-002 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50814-002-01 1 in 1 BOX 1 4.5 g in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/08/2018 Part 3 of 7 BURN TREATMENTÂ
benzalkonium chloride, lidocaine hydrochloride creamProduct Information Item Code (Source) NDC:50814-014 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 HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX)  WATER (UNII: 059QF0KO0R)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50814-014-01 10 in 1 BOX 1 0.9 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/08/2018 Part 4 of 7 ALCOHOL CLEANSINGÂ
isopropyl alcohol clothProduct Information Item Code (Source) NDC:50814-012 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 g  in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50814-012-01 20 in 1 BOX 1 0.9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/08/2018 Part 5 of 7 ANTIBIOTIC APPLICATIONÂ
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Item Code (Source) NDC:50814-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU]  in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU]  in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP)  PETROLATUM (UNII: 4T6H12BN9U)  WATER (UNII: 059QF0KO0R)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50814-013-01 10 in 1 BOX 1 0.9 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 02/08/2018 Part 6 of 7 HAND SANITIZERÂ
alcohol gelProduct Information Item Code (Source) NDC:50814-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 g  in 1 g Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  WATER (UNII: 059QF0KO0R)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50814-015-01 6 in 1 BOX 1 0.9 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/08/2018 Part 7 of 7 EYE WASHÂ
water solutionProduct Information Item Code (Source) NDC:50814-010 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 991 mg  in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50814-010-01 1 in 1 BOX 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 02/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349B 02/08/2018 Labeler - GFA Production (Xiamen) Co., Ltd. (421256261) Establishment Name Address ID/FEI Business Operations GFA Production (Xiamen) Co., Ltd. 421256261 manufacture(50814-031, 50814-011, 50814-002, 50814-014, 50814-012, 50814-013, 50814-015, 50814-010)