Label: ROHTO COOL- naphazoline hydrochloride and polysorbate 80 liquid

  • NDC Code(s): 66613-8142-1, 66613-8142-2
  • Packager: Rohto Pharmaceutical Co Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/14

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  • Active ingredients

    Naphazoline hydrochloride 0.012%

    Polysorbate 80 0.2%

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  • Purpose

    Naphazoline hydrochloride - Redness reliever

    Polysorbate - Lubricant

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  • Uses

    relieves redness of the eye due to minor eye irritations
    temporarily relieves burning and irritation due to dryness of the eye
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  • 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
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  • Keep Out of Reach of Children.

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

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  • Directions

    put 1 or 2 drops in the affected eye(s) up to 4 times daily
    tightly snap on cap to seal

    Other information

    do not store above 25°C (77°F)
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  • Inactive ingredients

    alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, purified water, sodium borate

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  • Questions?

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

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ROHTO COOL 
    naphazoline hydrochloride, polysorbate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66613-8142
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE 0.12 mg  in 1 mL
    POLYSORBATE 80 (POLYSORBATE 80) POLYSORBATE 80 2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    BENZALKONIUM CHLORIDE  
    BORIC ACID  
    CHLOROBUTANOL  
    EDETATE DISODIUM  
    MENTHOL  
    WATER  
    SODIUM BORATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66613-8142-1 1 in 1 CARTON 08/21/2001
    1 13 mL in 1 BOTTLE; Combination Product Type = C112160
    2 NDC:66613-8142-2 7 mL in 1 BOTTLE; Combination Product Type = C112160 10/01/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 08/21/2001
    Labeler - Rohto Pharmaceutical Co Ltd (690573662)
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