Label: DRY EYE FORMULA LUBRICANT EYE DROPS- glycerin propylene glycol solution/ drops
- NDC Code(s): 72985-001-03
- Packager: Eye Essentials 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 December 1, 2021
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- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
Do not use if solution changes color or becomes cloudy
When using this product
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- do not touch tip of container to any surface to avoid contamination
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- remove contact lenses before using
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- replace cap after use
Stop use and ask a doctor if
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- you experience eye pain, changes in vision, continued redness or irritation of the eye
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- condition worsens or persists for more than 72 hours
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
DRY EYE FORMULA LUBRICANT EYE DROPS
glycerin propylene glycol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72985-001 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 3 mg in 1 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72985-001-03 3 in 1 CARTON 11/02/2020 1 15 mL in 1 BOTTLE; 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 11/02/2020 Labeler - Eye Essentials LLC (117007610) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 114406598 MANUFACTURE(72985-001)