Label: DORAMA-NEO- water liquid

  • NDC Code(s): 49873-020-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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  • ACTIVE INGREDIENT

    Active ingredient    Purified water 98.4%

  • PURPOSE

    Purpose    Eyewash

  • INDICATIONS & USAGE

    Uses  For cleansing the eye to help relieve these symptoms by removing loose foreign material, air pollutants (smog or pollen) or chlorinated water:
    ■irritation  ■discomfort  ■burning  ■stinging  ■smarting  ■itching

  • WARNINGS

    Warnings
    For external use only

    Do not use if solution changes color or becomes cloudy

    When using this product
    ■to avoid contamination, do not touch tip of container to any surface
    ■replace cap after using

    Ask a doctor if you experience
    ■eye pain ■changes in vision
    ■continued redness or irritation of the eye
    ■or if the condition worsens or persists

    Obtain immediate medical treatment for all open wounds in or near the eyes

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

  • DOSAGE & ADMINISTRATION

    Directions  Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

  • INACTIVE INGREDIENT

    Inactive ingredients benzalkonium chloride, boric acid, calcium chloride, edetate disodium, potassium chloride, sodium borate, sodium chloride

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    DORAMA-NEO 
    water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-020
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-020-011 in 1 CARTON11/08/1983
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01811/08/1983
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-020) , label(49873-020) , pack(49873-020)
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