ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]

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ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]
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NDC 10742-8142-1
Set ID 69166dec-fb86-4c76-9efe-88c3bb12a8f0
Category HUMAN OTC DRUG LABEL
Packager The Mentholatum Company
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active ingredients

    Naphazoline hydrochloride 0.012%

    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
  • 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

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

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

  • Questions?

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

  • Package/Label Principal Display Panel

    Rohto Cool
  • INGREDIENTS AND APPEARANCE
    ROHTO  COOL
    naphazoline hydrochloride, polysorbate 80 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8142
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE.12 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) 1 mg  in 1 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CHLOROBUTANOL (UNII: HM4YQM8WRC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8142-11 in 1 CARTON08/21/2001
    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 finalpart34908/21/2001
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rohto-Mentholatum (Vietnam) Co. Ltd.555347535MANUFACTURE(10742-8142)
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