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Sato Clear (Sato Pharmaceutical Co., Ltd.)

Available Formats

Dosage Form Package Information Links
SOLUTION/ DROPS 1 BOTTLE, PLASTIC in 1 CARTON (49873-044-01) > 15 mL in 1 BOTTLE, PLASTIC Label Information

Complete Sato Clear Information

  • ACTIVE INGREDIENT

    Active ingredient
    Naphazoline hydrochloride 0.012%


  • PURPOSE

    Purpose
    Naphazoline hydrochloride      Vasoconstrictor


  • INDICATIONS & USAGE

    Uses relieves this symptom due to minor eye irritations
    â–  redness of the eye


  • WARNINGS

    Warnings

    For external use only

    Do not use

    • if solution changes color or becomes cloudy

    Ask a doctor before use if you have

    • narrow angle glaucoma

    When using this product

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

    Stop use and ask a doctor if you experience

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye
    • the condition worsens or persists for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

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


  • DOSAGE & ADMINISTRATION

    Directions
    â–  Place 1 or 2 drops in the affected eyes up to 4 times daily.


  • OTHER SAFETY INFORMATION

    Other information

    • use only if imprinted tamper-resistant seal on the bottle cap is intact
    • keep container tightly closed
       

  • INACTIVE INGREDIENT

    Inactive ingredients benzalkonium chloride, boric acid, dl-camphor, sodium borate, sodium chloride, purified water.


  • INGREDIENTS AND APPEARANCE
    SATO CLEAR 
    naphazoline hydrochloride solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-044
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 12 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49873-044-01 1 in 1 CARTON
    1 15 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 05/31/1989
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    Name Address ID/FEI Business Operations
    Sato Pharmaceutical Co., Ltd. 715699133 manufacture(49873-044) , label(49873-044) , pack(49873-044)