Label: ROHTO DIGI-EYE- hypromellose, tetrahydrozoline hydrochloride liquid

  • NDC Code(s): 10742-8175-1
  • 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 February 8, 2023

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  • Active ingredients

    Hypromellose 0.35%

    Tetrahydrozoline hydrochloride 0.05%

  • Purpose

    Hypromellose - Lubricant

    Tetrahydrozoline hydrochloride - Redness reliever

  • Uses

    • temporarily relieves burning and irritation due to dryness of the eye
    • relieves redness of the eye due to minor eye irritations
  • Warnings

    For external use only

    Ask a doctor before use if you have

    narrow angle glaucoma

    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
    • overuse may cause more eye redness
    • pupils may become enlarged temporarily
    • remove contact lenses before using

    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 lasts 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) up to 4 times daily
    • tightly snap on cap to seal

    Other information

    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    benzalkonium chloride, boric acid, chlorobutanol, cyanocobalamin, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate

  • Questions or comments?

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

  • Package/Label Principal Display Panel

    Rohto Digi Eye
  • INGREDIENTS AND APPEARANCE
    ROHTO DIGI-EYE 
    hypromellose, tetrahydrozoline hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8175
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED3.5 mg  in 1 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CHLOROBUTANOL (UNII: HM4YQM8WRC)  
    CYANOCOBALAMIN (UNII: P6YC3EG204)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
    WATER (UNII: 059QF0KO0R)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8175-11 in 1 CARTON03/01/2018
    113 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/01/2018
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rohto-Mentholatum (Vietnam) Co. Ltd.555347535manufacture(10742-8175)
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