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Optic Splash (Sato Pharmaceutical, Co., Ltd.)

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SOLUTION/ DROPS 1 BOTTLE in 1 CARTON (49873-501-01) > 15 mL in 1 BOTTLE Label Information

Complete Optic Splash Information

  • ACTIVE INGREDIENT

    Active ingredients
    Glycerin 0.2%
    Naphazoline hydrochloride 0.02%


  • PURPOSE

    Purpose
    Glycerin     Lubricant
    Naphazoline hydrochloride     Redness reliever


  • INDICATIONS & USAGE

    Uses
    â–  Relieves redness of the eye due to minor eye irritations.
    â–  Temporarily relieves burning and irritation due to dryness of the eye.


  • WARNINGS

    Warnings
    For external use only

    Do not use
    â–  if solution changes color or becomes cloudy

    Ask a doctor before use if you have
    â–  narrow angle glaucoma

    When using this product
    â–  to avoid contamination, do not touch tip of container to any surface
    â–  replace cap after using
    â–  overuse of this product may produce increased redness of the eye
    â–  pupils may become enlarged temporarily

    Stop use and ask a doctor if
    â–  you experience:
        â–  eye pain    â–  changes in vision
        â–  continued redness or irritation of the eye
    â–  condition worsens or persists for more than 72 hours

    Keep our of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    Directions
    Instill 1 to 2 drops in the affected eye(s) up to four times daily.


  • OTHER SAFETY INFORMATION

    Other information
    â–  store tightly closed, protected from light.


  • INACTIVE INGREDIENT

    Inactive ingredients
    benzalkonium chloride, boric acid, camphor, menthol, polysorbate 80, potassium chloride, purified water, sodium borate, sodium chloride


  • PRINCIPAL DISPLAY PANEL

    opticsplashcart.jpgcarton


  • PRINCIPAL DISPLAY PANEL

    opticsplashPDP.jpgPDP


  • INGREDIENTS AND APPEARANCE
    OPTIC SPLASH 
    naphazoline hydrochloride, glycerin solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-501
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 20 mg  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 200 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49873-501-01 1 in 1 CARTON
    1 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 01/22/2008
    Labeler - Sato Pharmaceutical, Co., Ltd. (690575642)
    Establishment
    Name Address ID/FEI Business Operations
    Sato Pharmaceutical, Co. Ltd. 715699133 manufacture, label, pack