Label: FAD FIRST AID DIRECT EYEWASH- purified water solution
XPECT FIRST AID BUFFERED EYEWASH- purified water solution
EYEWASH FLUSHING SOLUTION- purified water solution
XPECT FIRST AID BUFFERED EYE AND SKIN- purified water solution
FAD FIRST AID DIRECT BUFFERED EYE AND SKIN- purified water solution
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Contains inactivated NDC Code(s)
NDC Code(s): 42961-090-01, 42961-091-01, 42961-091-02, 42961-092-01, view more42961-093-01, 42961-094-01, 42961-094-02 - Packager: Cintas Corporation
- 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 July 15, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
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- If solution changes color or becomes cloudy
When using this product
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- Remove contact lenses before using
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- Avoid contamination, do not touch tip of container to any surface
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- Do not reuse, once open, discard
Stop use and ask a doctor if
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- You experience eye pain
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- Changes in vision occur
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- Continued redness or irritation of the eye or if the condition worsens or persists
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- Obtain immediate medical treatment for all open wounds in or near the eyes
- Directions
- Other information
- Inactive ingredients
- Package /Label Principal Display Panel – fad first aid direct Eyewash
- Package/Label Principal Display Panel – Xpect First aid Buffered Eyewash
- Package/Label Principal Display Panel – Eyewash Flushing Solution
- Package/Label Principal Display Panel – Xpect First aid Buffered Eye & Skin
- Package/Label Principal Display Panel – fad first aid direct Buffered Eye & Skin
- Package/Label Principal Display Panel – fad first aid direct Buffered Eye & Skin
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INGREDIENTS AND APPEARANCE
FAD FIRST AID DIRECT EYEWASH
purified water solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-090 Route of Administration OPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 985.77 g in 1000 mL Inactive Ingredients Ingredient Name Strength POLIHEXANIDE (UNII: 322U039GMF) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-090-01 15 mL in 1 VIAL, SINGLE-USE 07/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 07/15/2014 XPECT FIRST AID BUFFERED EYEWASH
purified water solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-091 Route of Administration OPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 985.77 g in 1000 mL Inactive Ingredients Ingredient Name Strength POLIHEXANIDE (UNII: 322U039GMF) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-091-02 5 in 1 BOX 07/15/2014 1 NDC:42961-091-01 15 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 07/15/2014 EYEWASH FLUSHING SOLUTION
purified water solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-092 Route of Administration OPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 985.77 g in 1000 mL Inactive Ingredients Ingredient Name Strength POLIHEXANIDE (UNII: 322U039GMF) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-092-01 118 mL in 1 BOTTLE, PLASTIC 07/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 07/15/2014 XPECT FIRST AID BUFFERED EYE AND SKIN
purified water solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-093 Route of Administration OPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 985.77 g in 1000 mL Inactive Ingredients Ingredient Name Strength POLIHEXANIDE (UNII: 322U039GMF) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-093-01 118 mL in 1 BOTTLE, PLASTIC 07/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 07/15/2014 FAD FIRST AID DIRECT BUFFERED EYE AND SKIN
purified water solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-094 Route of Administration OPHTHALMIC, IRRIGATION, TOPICAL, CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 985.77 g in 1000 mL Inactive Ingredients Ingredient Name Strength POLIHEXANIDE (UNII: 322U039GMF) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-094-01 236 mL in 1 BOTTLE, PLASTIC 07/15/2014 2 NDC:42961-094-02 474 mL in 1 BOTTLE, PLASTIC 07/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 07/15/2014 Labeler - Cintas Corporation (056481716)
