MINIDROPS - lubricant eye drops liquid Optics Laboratory, Inc 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. ---------- ACTIVE INGREDIENTS SECTION ACTIVE INGREDIENTS (IN EACH ML) POLYVINYLPRROLIDONE 6 MG POLYVINYL ALCOHOL 14 MG PURPOSE VISCOSITY 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:
MINIDROPS lubricant eye drops liquid Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:6 410 8-212 Route of Ad minis tration OPHTHALMIC Active Ing redient/active Moiety Ing redient Name Basis o f Streng th Streng th PO VIDO NE K3 0 (UNII: U725QWY32X) (POVIDONE K30 - UNII:U725QWY32X) POVIDONE K30.6 ml in 10 0 ml PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 ) (POLYVINYL ALCOHOL - UNII:532B59 J9 9 0 ) POLYVINYL ALCOHOL 1.4 ml in 10 0 ml Inactive Ing redients Ing redient Name SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) WATER (UNII: 0 59 QF0 KO0 R).9 ml in 10 0 ml 9 7.1 ml in 10 0 ml Streng th
Packag ing # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date 1 NDC:6 410 8-212-13 5 in 1 BOX 1 NDC:6 410 8-212-10 0.5 ml in 1 VIAL, SINGLE-USE 2 NDC:6 410 8-212-12 30 in 1 BOX 2 NDC:6 410 8-212-10 0.5 ml in 1 VIAL, SINGLE-USE Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part349 0 4/0 1/19 9 1 Labeler - O ptics Laboratory, Inc (018503552) Registrant - O ptics Laboratory, Inc (018503552) Establishment Name Addre ss ID/FEI Busine ss Ope rations Taiwan Bio tech Co, Ltd 6 56 1279 33 manufacture Establishment Name Addre ss ID/FEI Busine ss Ope rations Optics Labo rato ry, Inc 0 18 50 3552 manufacture Revised: 1/2010 Optics Laboratory, Inc