Label: MINIDROPS- lubricant eye drops liquid

  • NDC Code(s): 64108-212-10, 64108-212-12, 64108-212-13, 64108-212-65
  • Packager: Optics Laboratory, Inc
  • 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 March 2, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS SECTION

    POVIDONE  0.6%

    POLYVINYL ALCOHOL  1.4%

  • PURPOSE SECTION

    EYE LUBRICANT

  • KEEP OUT OF REACH OF CHILDREN SECTION

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • INDICATIONS AND USE SECTION

    USES FOR TEMPORARY RELIEF OF BURNING AND IRRITATION DUE TO DRYNESS OF THE EYE

    FOR USE AS A PROTECTANT AGAINST FURTHER IRRITATION OR TO RELIEVE DRYNESS OF THE EYE

  • WARNINGS SECTION

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

    IF YOU EXPERIENCE EYE PAIN, CHANGES IN VISION, CONTINUED REDNESS OR IRRITATION OF THE EYE, OR IF THE CONDITIONS WORSENS OR PERSISTS FOR MORE THAN 72 HOURS, DISCONTINUE USE AND CONSULT A DOCTOR. IF SOLUTION CHANGES COLOR OR BECOMES CLOUDY, DO NOT USE

    OTHER INFORMATION  STORE AT ROOM TEMPERATURE 15-30 DEGREES C (59-86 DEGREES F)

  • DOSAGE AND ADMINISTRATION SECTION

    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.

  • INACTIVE INGREDIENTS SECTION

    SODIUM CHLORIDE, WATER (PURIFIED)

  • QUESTIONS SECTION

    QUESTIONS OR COMMENTS? 800-968-6788

  • PACKAGE LABEL

    MINIDROPS LUBRICANT EYE DROPS DROPPER

    INDIVIDUAL PACKAGE TO AVOID CROSS-CONTAMINATION FROM REPEATED USE

    COMPACT MINI-SIZE EASY TO CARRY OPTICS MANUFACTURED FOR OPTICS LABORATORY INC.EL MONTE, CA 91731 USA MADE IN TAIWAN

    STERILE PRESERVATIVE FREE USE ONLY IF SINGLE-USE DROPPER IS INTACT  USE AS A PROTECTANT AGAINST FURTHER IRRITATION OR TO RELIEVE DRYNESS OF THE EYE  PRESERVATIVE-FREE FORMULA SAFE FOR DAILY USE  SINGLE-USE DROPPERS, CONVENIENT TO USE AND CARRY

    MINIDROPS AND OPTIC LABORATORY ARE TRADEMARKS OF OPTIC LABORATORY INC

    MiniDrops plastic sleeve v5

    MiniDrops 30 retail v11

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  • INGREDIENTS AND APPEARANCE
    MINIDROPS 
    lubricant eye drops liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64108-212
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED6.0 mg  in 1 mL
    POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL14.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) .9 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 97.1 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64108-212-135 in 1 BOX04/01/1991
    1NDC:64108-212-100.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:64108-212-1230 in 1 BOX04/01/1991
    2NDC:64108-212-100.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    3NDC:64108-212-6565 in 1 BOX04/01/1991
    3NDC:64108-212-100.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/01/1991
    Labeler - Optics Laboratory, Inc (018503552)
    Registrant - Optics Laboratory, Inc (018503552)