Label: ARTIFICIAL TEARS- lubricant eye drops solution/ drops
- NDC Code(s): 11822-0011-3, 11822-0011-5
- Packager: RITE AID 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 September 23, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- 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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- 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
- Questions or comments?
- Principal Display Panel – 30 mL Carton
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INGREDIENTS AND APPEARANCE
ARTIFICIAL TEARS
lubricant eye drops solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0011 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:11822-0011-3 1 in 1 CARTON 01/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:11822-0011-5 1 in 1 CARTON 01/01/2017 2 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 01/01/2017 Labeler - RITE AID CORPORATION (014578892) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 114406598 MANUFACTURE(11822-0011)