Label: ROHTO DUAL LIGHT RELIEF- hypromellose, povidone liquid
- NDC Code(s): 66613-8459-1
- Packager: Rohto Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2024
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- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
- do not use if solution changes color or becomes cloudy
- Directions
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
ROHTO DUAL LIGHT RELIEF
hypromellose, povidone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66613-8459 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE 5 mg in 1 mL HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength CHLOROBUTANOL (UNII: HM4YQM8WRC) WATER (UNII: 059QF0KO0R) TAURINE (UNII: 1EQV5MLY3D) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) BORIC ACID (UNII: R57ZHV85D4) ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) LEVOMENTHOL (UNII: BZ1R15MTK7) EDETATE DISODIUM (UNII: 7FLD91C86K) ALGINIC ACID (UNII: 8C3Z4148WZ) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM BORATE (UNII: 91MBZ8H3QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66613-8459-1 1 in 1 CARTON 05/30/2024 1 18 mL in 1 BOTTLE, DISPENSING; 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 05/30/2024 Labeler - Rohto Pharmaceutical Co., Ltd. (690573662) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 label(66613-8459) Establishment Name Address ID/FEI Business Operations Rohto Pharmaceutical Co., Ltd. 696604024 manufacture(66613-8459)