ROHTO JOLT (HYPROMELLOSE) LIQUID [THE MENTHOLATUM COMPANY]

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ROHTO JOLT (HYPROMELLOSE) LIQUID [THE MENTHOLATUM COMPANY]
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NDC 10742-8194-1
Set ID 0dc29577-6b66-428b-a46b-546973654841
Category HUMAN OTC DRUG LABEL
Packager The Mentholatum Company
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active ingredient

    Hypromellose 0.35%

  • Purpose

    Hypromellose - Lubricant

  • Uses

    •
    temporarily relieves discomfort due to minor irritations of the eye or exposure to wind and sun
    •
    lubricates to prevent further irritation or to relieve dryness of the eye
  • Warnings

    For external use only

    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
    •
    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) as needed
    •
    tightly snap on cap to seal
  • Other Information

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

    benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate

  • Questions or comments?

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

  • Package/Label Principal Display Panel

    Rohto Jolt Drug Facts
  • INGREDIENTS AND APPEARANCE
    ROHTO JOLT 
    hypromellose liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8194
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE 2906 (4000 MPA.S) (UNII: 5EYA69XGAT) (HYPROMELLOSE 2906 (4000 MPA.S) - UNII:5EYA69XGAT) HYPROMELLOSE 2906 (4000 MPA.S)3.5 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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
    WATER (UNII: 059QF0KO0R)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8194-11 in 1 CARTON10/01/2017
    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 finalpart34910/01/2017
    Labeler - The Mentholatum Company (002105757)
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