Label: REFRESH OPTIVE MEGA-3- carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ drops
- NDC Code(s): 0023-5773-05, 0023-5773-30, 0023-7151-60
- Packager: Allergan, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 30, 2022
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- Active ingredients
- Purpose
- Uses
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Warnings
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For external use only.
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To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
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Do not touch unit-dose tip to eye.
- If solution changes color, do not use.
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For external use only.
- Directions
- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REFRESH OPTIVE MEGA-3
carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0023-7151 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM 5 mg in 1 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 10 mg in 1 mL POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 80 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) CASTOR OIL (UNII: D5340Y2I9G) ERYTHRITOL (UNII: RA96B954X6) LINSEED OIL (UNII: 84XB4DV00W) LEVOCARNITINE (UNII: 0G389FZZ9M) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) WATER (UNII: 059QF0KO0R) TREHALOSE (UNII: B8WCK70T7I) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain SODIUM HYDROXIDE (UNII: 55X04QC32I) May contain HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0023-7151-60 60 in 1 BOX 06/15/2021 1 0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 06/15/2021 REFRESH OPTIVE MEGA-3
carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0023-5773 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM 5 mg in 1 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 10 mg in 1 mL POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 80 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) CASTOR OIL (UNII: D5340Y2I9G) ERYTHRITOL (UNII: RA96B954X6) LINSEED OIL (UNII: 84XB4DV00W) LEVOCARNITINE (UNII: 0G389FZZ9M) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) WATER (UNII: 059QF0KO0R) TREHALOSE (UNII: B8WCK70T7I) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain SODIUM HYDROXIDE (UNII: 55X04QC32I) May contain HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0023-5773-05 5 in 1 BOX 05/30/2017 1 0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 2 NDC:0023-5773-30 30 in 1 BOX 05/30/2017 2 0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 05/30/2017 Labeler - Allergan, Inc. (144796497)