Label: EYESALINE CONCENTRATE- water liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 64809-104-18, 64809-104-19 - Packager: Sperian Eye & Face Protection Inc.
- 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 March 21, 2018
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- Obtain immidiate medical treatment for all open wounds in or near the eyes. To avoid contamination, do not touch tip of container to any surface. Replace cap after use.
Do not use
- in concentrated form
- while wearing contact lenses
- if solution changes color or becomes cloudy
- for injection
- in intraocular surgery
- internally
- if eye is lacerated or object is embedded
- if seal is broken
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Directions
- Concentrate must be diluted (1) part concentrate to (10) parts potable water before use
- Prepare sufficient quantity of constituted eyewash solution in advance of an emergency
- Mix concentrate with potable water to prepare eyewash solution as follows:
- Determine quantity of eyewash solution required
- Follow sanitary procedures
- Wear protective eyewear and gloves
- Pour 1/3 of required amount of potable water into mixing container or eyewash unit
- Add 1/3 of required amount of concentrate to water
- Agitate or mix thoroughly
- Repeat until required amount of solution is prepared
- Properly dispose of empty bottle after use
Do not reuse.
- Replace solution no longer than (6) months after mixing
- Other information
- Inactive ingredients
- Questions?
- Package Label
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INGREDIENTS AND APPEARANCE
EYESALINE CONCENTRATE
water liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64809-104 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 92.2 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SODIUM CHLORIDE (UNII: 451W47IQ8X) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64809-104-18 2070 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/09/2011 2 NDC:64809-104-19 5323 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/09/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 09/08/2011 Labeler - Sperian Eye & Face Protection Inc. (013435034) Establishment Name Address ID/FEI Business Operations Sperian Eye & Face Protection Inc 013435034 manufacture(64809-104)
