Label: OCTIQ LUBRICANT EYE DROPS- dextran 70 hypromellose solution/ drops
- NDC Code(s): 57483-610-15
- Packager: Innovus Pharmaceuticals, Inc.
- 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 31, 2022
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- Do not use
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INGREDIENTS AND APPEARANCE
OCTIQ LUBRICANT EYE DROPS
dextran 70 hypromellose solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57483-610 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70 1 mg in 1 mL HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35) HYPROMELLOSE 2910 (4000 MPA.S) 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM CHLORIDE (UNII: 660YQ98I10) POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57483-610-15 2 in 1 CARTON 11/14/2021 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 11/14/2021 Labeler - Innovus Pharmaceuticals, Inc. (962507187) Establishment Name Address ID/FEI Business Operations AMMAN PHARMACEUTICAL INDUSTRIES 534677849 manufacture(57483-610)