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

    Hypromellose 0.3%

    Povidone 0.5%

  • Purpose

    Hypromellose – Lubricant

    Povidone - Lubricant

  • Uses

    • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
    • protects against further irritation or to relieve dryness of the eye

  • 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

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eyes lasts
    • condition worsens or persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • put 1 or 2 drops in the affected eye(s) as needed
    • tightly snap on cap to seal

    Other information

    • do not store above 25 OC (77 OF)
  • Inactive ingredients

    alginic acid, anhydrous citric acid, boric acid, camphor, chlorobutanol, edetate disodium, menthol, polysorbate 80, purified water, sodium borate, sodium citrate, taurine, zinc sulfate

  • Questions?

    1-877-636-2677 MON-FRI 9AM-5PM (EST)

  • PRINCIPAL DISPLAY PANEL

  • Principal Display Panel

    Image 01

  • INGREDIENTS AND APPEARANCE
    ROHTO  DUAL LIGHT RELIEF
    hypromellose, povidone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66613-8459
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE5 mg  in 1 mL
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66613-8459-11 in 1 CARTON05/30/2024
    118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01805/30/2024
    Labeler - Rohto Pharmaceutical Co., Ltd. (690573662)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757label(66613-8459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rohto Pharmaceutical Co., Ltd.696604024manufacture(66613-8459)