Label: ROHTO ICE- hypromellose, tetrahydrozoline hydrochloride, zinc sulfate liquid

  • NDC Code(s): 10742-8143-1
  • 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 0.2%

    Tetrahydrozoline HCl 0.05%

    Zinc sulfate 0.25%

  • Purpose

    Hypromellose - Lubricant

    Tetrahydrozoline HCl - Redness reliever

    Zinc sulfate - Astringent

  • Uses

    • temporarily relieves redness of the eye and discomfort due to
      • minor eyes irritations
      • exposure to wind or sun
    • temporarily relieves burning and irritation due to dryness of the eye
  • 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

    boric acid, edetate disodium, menthol, polysorbate 80, purified water, sodium borate

  • Questions?

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

  • Package/Label Principal Display Panel

    Rohto Ice
  • INGREDIENTS AND APPEARANCE
    ROHTO   ICE
    hypromellose, tetrahydrozoline hydrochloride, zinc sulfate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8143
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED2 mg  in 1 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE, UNSPECIFIED FORM2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8143-11 in 1 CARTON09/27/2005
    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 finalpart34909/27/2005
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rohto-Mentholatum (Vietnam) Co. Ltd.555347535manufacture(10742-8143)
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