Label: ROHTO SUN AND SPORT- hypromellose, povidone liquid

  • NDC Code(s): 10742-8140-1
  • Packager: The Mentholatum Company
  • 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 April 14, 2023

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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

    Carton
  • INGREDIENTS AND APPEARANCE
    ROHTO   SUN AND SPORT
    hypromellose, povidone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8140
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED3 mg  in 1 mL
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CHLOROBUTANOL (UNII: HM4YQM8WRC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    RACEMENTHOL (UNII: YS08XHA860)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    TAURINE (UNII: 1EQV5MLY3D)  
    ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8140-11 in 1 CARTON07/01/2022
    118 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/01/2022
    Labeler - The Mentholatum Company (002105757)
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