QUALITY CHOICE ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990), POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)

Available from:

Chain Drug Marketing Association, Inc.

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

​Purpose Polyvinyl alcohol: Eye Lubricant Povidone: Eye Lubricant Uses : - for use as a protectant against further irritation or to relieve dryness of the eye - for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Authorization status:

OTC monograph final

Summary of Product characteristics

QUALITY CHOICE ARTIFICIAL TEARS- POLYVINYL ALCOHOL, POVIDONE SOLUTION/
DROPS
CHAIN DRUG MARKETING ASSOCIATION, INC.
----------
QUALITY CHOICE ARTIFICIAL TEARS15 ML (PLD)
_​ACTIVE INGREDIENTS_
Polyvinyl alcohol 0.5%
Povidone 0.6%
_​PURPOSE_
Polyvinyl alcohol: Eye Lubricant
Povidone: Eye Lubricant
_USES_:
for use as a protectant against further irritation or to relieve
dryness of the eye
for the temporary relief of discomfort due to minor irritations of the
eye, or to
exposure to wind or sun
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE THIS PRODUCTIF solution changes color or becomes cloudy
STOP USE AND ASK A DOCTOR IF YOU EXPERIENCE
eye pain
changes in vision
continued redness or irritation of the eye or if the condition worsens
or persists for
more than 72 hours
WHEN USING THIS PRODUCT
to avoid contamination, do not touch tip of container to any surface
replace cap after using. Keep container tightly closed
remove contact lens before using
KEEP OUT OF THE REACH OF CHILDREN. If accidentally swallowed, get
medical help or
contact a Poison Control Center immediately.
_DIRECTIONS_
Instill 1 or 2 drops in the affected eye(s) as needed.
_OTHER INFORMATION_
Tamper Evident. Do not use this product if imprinted neckband is
missing or broken.
RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at 15°-30°C (59°-86°F)
_INACTIVE INGREDIENTS_
benzalkonium chloride, dextrose, edetate disodium, potassium chloride,
purified water,
sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate
dibasic, and
sodium phosphate monobasic
QUALITY CHOICE ARTIFICIAL TEARS
polyvinyl alcohol, povidone solution/ drops
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63868-223
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL -
UNII:532B59J990)
POLYVINYL ALCOHOL
500 mg
in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)
POVIDONE
600 mg
in 100 mL
Chain Drug Marketing Association, Inc.