OcuFresh by Optics Laboratory, Inc

OcuFresh by

Drug Labeling and Warnings

OcuFresh by is a Otc medication manufactured, distributed, or labeled by Optics Laboratory, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OCUFRESH- water 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.

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ACTIVE INGREDIENTS (in each ml)

PURIFIED WATER 98.8%

PURPOSE SECTION

EYE WASHING

INDICATIONS AND USE SECTION

FOR CLEANING THE EYE TO HELP RELIEVE IRRITATION, DISCOMFORT, BURNING, STINGING, SMARTING OR ITCHING BY REMOVING LOOSE FOREIGN MATERIAL, AIR POLLUTANTS (SMOG OR POLLEN) OR CHLORINATED WATER

WARNINGS SECTION

WARNINGS

TO AVOID CONTAMINATION, DO NOT TOUCH TIP OF CONTAINER TO ANY SURFACE.  DO NOT REUSE.  ONCE OPENED, DISCARD.  

IF YOU EXPERIENCE EYE PAIN, CHANGES IN VISION, CONTINUED REDNESS OR IRRITATION OF THE EYE, OR IF THE CONDITION WORSENS OR PERSISTS CONSULT A DOCTOR.  
OBTAIN IMMEDIATE MEDICAL TREATMENT FOR ALL OPEN WOUNDS IN OR NEAR THE EYES.

IF SOLUTION CHANGES COLOR OR BECOMES CLOUDY DO NOT USE.

DOSAGE AND ADMINISTRATION SECTION

DIRECTIONS
DO NOT DILUTE SOLUTION OR REUSE BOTTLE.  

WITHOUT CUP: HOLD CONTAINER A FEW INCHES ABOVE THE EYE.  CONTROL RATE OF FLOW BY PRESSURE ON BOTTLE.  FLUSH AFFECTED AREA AS NEEDED.

WITH CUP: RINSE CUP WITH CLEAN WATER IMMEDIATELY BEFORE EACH USE.  AVOID CONTAMINATION OF RIM AND INSIDE SURFACE OF CUP.  FILL CUP WITH HALF FULL AND APPLY THE CUP TO THE AFFECTED EYE, PRESSING TIGHTLY TO PREVENT THE ESCAPE OF THE LIQUID AND TILT THE HEAD BACKWARD.  OPEN EYELIDS WIDE AND ROTATE THE EYEBALL TO ENSURE THOROUGH BATHING WITH THE WASH.  RINSE CUP WITH CLEAN WATER AFTER EACH USE.

OTHER INFORMATION

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

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.

INACTIVE INGREDIENTS SECTION

SODIUM CHLORIDE 0.65% , SODIUM BORATE 0.02% , BORIC ACID 0.32%, BENZALKONIUM CHLORIDE 0.01%

QUESTIONS SECTION

QUESTIONS OR COMMENTS? 800-966-6788

PACKAGE LABEL

OPTICS OCUFRESH EYE WASH STERILE IN SINGLE-USE BOTTLES

THE SAFE CHOICE FOR CLEANSING YOUR EYES

6 STERILE SINGLE USE BOTTLES STERILE EYE CUP INCLUDED 0.68 FL OZ EA  (20 ML)EA

OcuFresh cleanses your eyes to remove pollen loose foreign material or chlorinated water to help relieve your eyes from

  • Irritation
  • Burning
  • Stinging
  • Discomfort

CONVENIENT AND EASY TO CARRY

USE ONLY IF TAB AND SINGLE-USE BOTTLES ARE INTACT

WWW.OCUFRESH.COM  OPTICS  MANUFACTURED FOR OPTICS LABORATORY, INC. EL MONTE CA 91731 USA MADE IN TAIWAN

LOT   EXP  

PATENT PENDING OPTICS LABORATORY AND OCUFRESH ARE TRADEMARKS OF OPTICS LABORATORY INC.

Optics_OcuFresh

res

OCUFRESH 
water liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64108-312
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
BORIC ACID (UNII: R57ZHV85D4)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64108-312-066 in 1 BOX01/15/202001/15/2020
1NDC: 64108-312-0120 mL in 1 DOSE PACK; Type 0: Not a Combination Product
2NDC: 64108-312-6060 in 1 BOX09/01/201101/15/2020
2NDC: 64108-312-0120 mL in 1 DOSE PACK; Type 0: Not a Combination Product
3NDC: 64108-312-2424 in 1 BOX09/01/201101/15/2020
3NDC: 64108-312-0120 mL in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/01/201101/15/2020
Labeler - Optics Laboratory, Inc (018503552)
Registrant - Optics Laboratory, Inc (018503552)

Revised: 1/2020
 
Optics Laboratory, Inc