Label: DORAMA DRY AID EYE DROPS- povidone, propylene glycol solution

  • NDC Code(s): 49873-503-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 17, 2024

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  • Active ingredients

    Povidone 0.68%

    Propylene glycol 0.3%

  • Purpose

    Povidone ............... Lubricant

    Propylene glycol .....Lubricant

  • Uses

    • temporarily relieves burning and irritation due to dryness of the eye
    • protects against further irritation or to relieve dryness of the eye
  • Warnings

    For external use only

    When using this product

    To avoid contamination

    • do not touch tip of container to any surface
    • 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 freeze
  • Inactive ingredients

    benzalkonium chloride, boric acid, calcium chloride, edetate disodium, menthol, polysorbate 80, purified water, sodium borate, sodium chloride.

  • Box label

    Box label

  • INGREDIENTS AND APPEARANCE
    DORAMA DRY AID EYE DROPS 
    povidone, propylene glycol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-503
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 g  in 100 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE0.68 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-503-011 in 1 CARTON01/13/202206/30/2025
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01801/13/202206/30/2025
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-503) , pack(49873-503) , label(49873-503)
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