Label: SATO CLEAR- naphazoline hydrochloride solution/ drops

  • NDC Code(s): 49873-044-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • ACTIVE INGREDIENT

    Active ingredient
    Naphazoline hydrochloride 0.012%

  • PURPOSE

    Purpose
    Naphazoline hydrochloride      Vasoconstrictor

  • INDICATIONS & USAGE

    Uses relieves this symptom due to minor eye irritations
    ■ 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
    ■ 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.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    SATO CLEAR 
    naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-044
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE12 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-044-011 in 1 CARTON05/31/1989
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01805/31/1989
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-044) , label(49873-044) , pack(49873-044)
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