LIQUITEARS- polyvinyl alcohol solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

POLYVINYL ALCOHOL

Composition:

POLYVINYL ALCOHOL 14 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

Lubricant - to prevent further irritation - to relieve dryness of the eye

Authorization status:

OTC monograph final

Summary of Product characteristics

LIQUITEARS - POLYVINYL ALCOHOL SOLUTION/ DROPS
H.J. HARKINS COMPANY, 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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ARTIFICIAL TEARS SOLUTION DRUG FACTS
ACTIVE INGREDIENT
Polyvinyl Alcohol 1.4%
PURPOS E
Lubricant
US ES
to prevent further irritation
to relieve dryness of the eye
WARNINGS
DO NOT USE if solution changes color or becomes cloudy
WHEN USING THIS PRODUCT
do not touch tip of container to any surface to avoid contamination
replace cap after use
STOP USE AND ASK A DOCTOR IF
you experience eye pain, changes in vision, continued redness or
irritation of the eye
condition worsens or persists for more than 72 hours
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away
DIRECTIONS
instill 1 to 2 drops in the affected eye(s) as needed
OTHER INFORMATION
store at 15° - 30°C (59° - 86°F)
keep tightly closed
INACTIVE INGREDIENTS
dibasic sodium phosphate, edetate disodium, monobasic sodium
phosphate, sodium chloride,
purified water. Phosphoric acid and/or sodium hydroxide may be added
to adjust pH. PRESERVATIVE
ADDED: benzalkonium chloride 0.01%
QUESTIONS ?
Serious side effects associated with use of this product may be
reported to 1800-323-0000
*MAJOR LIQUITEARS IS NOT MANUFACTURED OR DISTRIBUTED BY ALLERGAN, INC.
OWNER OF THE REGISTERED TRADEMARK, LIQUIFILM TEARS®.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
MAJOR®
NDC 0904-5017-35
LiquiTears
Polyvinyl Alcohol 1.4%
Lubricant Eye Drops (Sterile)
Relieves Burning due to Dryness of the Eye
Compare to Active Ingredient of Liquifilm Tears®*
1/2 FL. OZ. (15 mL)
Repacked by:
H.J. Harkins Company, Inc.
Grover Beach, CA 93433
LIQUITEARS
polyvinyl alcohol solution/ drops
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:529 59 -0 41(NDC:0 9 0 4-50 17)
ROUTE OF ADMINISTRATION
OPHTHALMIC
H.J. Harkins Company, Inc.
ACTIVE INGRE