Label: BUFFERED EYE-LERT- water liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0498-0160-16, 0498-0160-38 - Packager: North Safety Products
- 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 July 13, 2010
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- 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
- for injection
- in intraocular surgery
- internally
- if solution changes color or becomes cloudy
When using this product
- 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
- Questions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BUFFERED EYE-LERT
water liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-0160 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0160-16 473 mL in 1 BOTTLE, PLASTIC 2 NDC:0498-0160-38 946 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 06/06/2010 Labeler - North Safety Products (059980441) Registrant - North Safety Products (059980441) Establishment Name Address ID/FEI Business Operations North Safety Products 059980441 manufacture