Label: MINIDROPS- lubricant eye drops liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 1, 2010

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  • ACTIVE INGREDIENTS (in each ml)

    Polyvinylpyrrolidone 6 mg

    Polyvinyl Alcohol 14mg

  • PURPOSE

    PURPOSE      VISCOSITY

    PURPOSE      VISCOSITY
  • USE

    RELIEVES DRY EYES, DISCOMFORT AND MINOR IRRITATION

    PROTECTS AND SOOTHES EYE TIREDNESS, EYE STRESS
  • WARNINGS


    DO NOT USE IF THE SINGLE-USE DROPPER IS NOT INTACT.  TO AVOID CONTAMINATION, DO NOT TOUCH TIP OF DROPPER TO ANY SURFACE.  ONCE OPENED, DISCARD.

    STOP USE AND ASK A DOCTOR IF

    • THE SOLUTION CHANGES COLOR OR BECOMES CLOUDY
    • EXPERIENCE EYE PAIN
    • CHANGES IN VISION
    • CONDITION WORSENS OR PERSISTS FOR MORE THAN 72 HOURS.

    KEEP OUT OF REACH OF CHILDREN

     IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • TWIST OFF TAB COMPLETELY TO OPEN
    • INSTILL 1 TO 2 DROPS IN THE AFFECTED EYE(S) AS NEEDED
    • DISCARD DROPPER AND DO NOT REUSE
  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE 15-300 C (59-860 F)

  • INACTIVE INGREDIENT

    SODIUM CHLORIDE

  • QUESTIONS OR COMMENTS?

    800-968-6788








  • PRINCIPAL DISPLAY PANEL


    MINIDROPS RETAIL PACKAGE



    5PACK BOX


    5PACK BOX BACKPNL





  • INGREDIENTS AND APPEARANCE
    MINIDROPS 
    lubricant eye drops liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62622-124
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE K30 (UNII: U725QWY32X) (POVIDONE K30 - UNII:U725QWY32X) POVIDONE K30.6 mL  in 100 mL
    POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL1.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) .9 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 97.1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62622-124-255 in 1 BOX
    1NDC:62622-124-260.5 mL in 1 VIAL, SINGLE-USE
    2NDC:62622-124-2430 in 1 BOX
    2NDC:62622-124-260.5 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/01/1991
    Labeler - Taiwan Biotech Co, Ltd (656127933)
    Registrant - Taiwan Biotech Co, Ltd (656127933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taiwan Biotech Co, Ltd656127933manufacture
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