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
  • 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

    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
    ALCOHOL (UNII: 3K9958V90M)  
    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)  
    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 finalpart34905/05/2014
    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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