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 October 4, 2021

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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 HYDROCHLORIDE.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)