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OCUFRESH

Optics Laboratory Inc.

OCUFRESH (water) liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

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

TO AVOID CONTAMINATION, DO NOT TOUCH TIP OF CONTAINER TO ANY SURFACE.  DO NOT RE-USE.  ONCE OPEN, 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 MEDICAL TREATMENT FOR ALL OPEN WOUNDS IN OR NEAR THE EYES.

IF SOLUTION CHANGES COLOR OR BECOMES CLOUDY DO NOT USE.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

DO NOT DILUTE SOLUTION OR RE-USE BOTTLE.

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

WITH CUP, RINSE CUP WITH CLEAN WATER IMMEDIATELY BEFORE EACH USE.  AVOID CONTAMINATION OF RIM AND INSIDE SURFACE OF CUP.  FILL CUP 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 TEMPERATURE15-30 DEGREES C (59-86 DEGREES F)

KEEP OUT OF THE REACH OF CHILDREN

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

INACTIVE INGREDIENTS

SODIUM CHLORIDE
SODIUM BORATE
BORIC ACID
BANZAKONIUM CHLORIDE

PACKAGE LABEL

Occufresh.jpg

OCUFRESH

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS 800-966-6788

OCUFRESH

Water LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64108-313
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
water 0.988 mL

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BORATE
BORIC ACID
benzalkonium chloride

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64108-313-01 20 in 1 BOTTLE
2 NDC:64108-313-01 20 in 1 BOTTLE
3 NDC:64108-313-01 20 in 1 BOTTLE
4 NDC:64108-313-01 20 in 1 BOTTLE
5 NDC:64108-313-24 24 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2014-01-15


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