Label: ROHTO COOL MAX- naphazoline hydrochloride, polysorbate 80 liquid

  • NDC Code(s): 10742-8159-1
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active ingredients

    Naphazoline hydrochloride 0.03%

    Polysorbate 80 0.2%

  • Purpose

    Naphazoline hydrochloride - Redness reliever

    Polysorbate 80 - Lubricant

  • Uses

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

    For external use only

    Ask a doctor before use if you have

    narrow angle glaucoma

    When using this product

    • do not touch top 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

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

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

  • Questions?

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

  • Package/Label Principal Display Panel

    Rohto Cool Max
  • INGREDIENTS AND APPEARANCE
    ROHTO  COOL MAX
    naphazoline hydrochloride, polysorbate 80 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8159
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.3 mg  in 1 mL
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 802 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CHLOROBUTANOL (UNII: HM4YQM8WRC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8159-11 in 1 CARTON05/05/2014
    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 DrugM01805/05/2014
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757label(10742-8159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rohto-Mentholatum (Vietnam) Co. Ltd.555347535manufacture(10742-8159)
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