Label: ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 13985-601-15 - Packager: MWI
- 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 February 8, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
- Do not use if imprinted seal on the bottle neck is broken or missing.
- Do not use if solution changes color or becomes cloudy.
- To avoid contamination, do not touch tip of container to any surface.
- Replace cap after using.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARTIFICIAL TEARS
polyvinyl alcohol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13985-601 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED 14 mg in 1 mL Inactive Ingredients Ingredient Name Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) Edetate Disodium (UNII: 7FLD91C86K) Sodium Chloride (UNII: 451W47IQ8X) Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F) Sodium Phosphate, Monobasic, Anhydrous (UNII: KH7I04HPUU) Water (UNII: 059QF0KO0R) Sodium Hydroxide (UNII: 55X04QC32I) Hydrochloric Acid (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13985-601-15 1 in 1 CARTON 03/23/2015 1 15 mL in 1 BOTTLE, DROPPER; 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 03/23/2015 Labeler - MWI (019926120) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn 117696840 MANUFACTURE(13985-601) , ANALYSIS(13985-601) , STERILIZE(13985-601) , PACK(13985-601) , LABEL(13985-601)