Label: SYSTANE ULTRA- polyethylene glycol 400 and propylene glycol solution/ drops
- NDC Code(s): 0065-1431-05
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated June 21, 2011
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INGREDIENTS AND APPEARANCE
SYSTANE ULTRA
polyethylene glycol 400 and propylene glycol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-1431 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 400 4 mg in 1 mL Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength Aminomethylpropanol (UNII: LU49E6626Q) Boric Acid (UNII: R57ZHV85D4) Guar Gum (UNII: E89I1637KE) Polidronium Chloride (UNII: 6716Z5YR3G) Potassium Chloride (UNII: 660YQ98I10) Water (UNII: 059QF0KO0R) Sodium Chloride (UNII: 451W47IQ8X) Sorbitol (UNII: 506T60A25R) Hydrochloric Acid (UNII: QTT17582CB) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-1431-05 1 in 1 CARTON 1 10 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 11/30/2009 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Alcon Laboratories, Inc. 008018525 MANUFACTURE(0065-1431)