Minidrops Liquid
FDA Label NDC 64108-212

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Optics Laboratory, Inc for the product Minidrops (NDC 64108-212). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients section, warnings, inactive ingredients, other information storage and handling, keep out of reach of children, uses, questions, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients Section

ACTIVE INGREDIENTS (IN EACH ML)         PURPOSE

POLYVINYLPRROLIDONE 6 MG                  VISCOSITY

POLYVINYL ALCOHOL  14 MG                     VISCOSITY

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


Inactive Ingredients

SODIUM CHLORIDE

Other Information Storage And Handling

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

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.

Uses

INDICATIONS: FOR THE TEMPORARY RELIEF OF BURNING AND IRRITATION DUE TO DRYNESS OF THE EYE.  FOR USE AS A LUBRICANT TO PREVENT FURTHER IRRITATION OR TO RELIEVE DRYNESS OF THE EYE.

Questions

QUESTIONS OR COMMENTS 800-968-6788

Package Label

OPTICS LABORATORY MINIDROPS EYE THERAPY  LUBRICANT EYE DROPS  PRESERVATIVE FREE SOOTHING RELIEF FOR EYES

USE: RELIEVES DRY EYES, DISCOMFORT AND MINOR IRRITATION   PROTECTS AND SOOTHES EYE TIREDNESS, EYE STRESS

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  RELIEVES DRY EYES, DISCOMFORT AND MINOR IRRITATION RESULTING FROM LENGTHY DRIVING TIME AND OVEREXPOSURE TO HEATERS AND AIR CONDITIONERS.  PROTECTS AND SOOTHES COMPUTER INDUCED EYE TIREDNESS, STRESS AND DRYNESS.  PRESERVATIVE FREE FORMULA RECOMMENDED FOR SAFE DAILY USE.  MOISTURIZED YOUR EYES WITH LASTING LUBRICANT LIKE NATURAL TEARS.STERILE SINGLE-USE DROPPERS 0.02 FL OZ EA  (0.5) ml EA  INDIVIDUAL PACKAGE TO AVOID CROSS-CONTAMINATION FROM REPEATED USE.  BIODEGRADEABLE / TOXIC-FREE MATERIAL SAFE FOR OUR ENVIRONMENT  COMPATE MINI-SIZE EASY TO CARRY

OPTICS LABORATORY AND MINIDROPS ARE TRADEMARKS OF OPTICS LABORATORIES, INC  OPTICS LABORATORY MANUFACTURED FOR: OPTICS LABORATORY, INC.  EL MONTE CA 91731  USE  MADE IN TAIWAN.  WWW.MINIDROPS.COM  

EXP:______________ LOT:________________ 


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