ARTIFICIAL TEARS- 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:

A-S Medication Solutions

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

Lubricant - relieves dryness of the eye - prevents further irritation

Product summary:

Product: 50090-0252 NDC: 50090-0252-0 15 mL in a BOTTLE

Authorization status:

OTC monograph final

Summary of Product characteristics

ARTIFICIAL TEARS- POLYVINYL ALCOHOL SOLUTION/ DROPS
A-S MEDICATION SOLUTIONS
_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._
----------
ARTIFICIAL TEARS SOLUTION DRUG FACTS
ACTIVE INGREDIENT
Polyvinyl Alcohol 1.4%
PURPOS E
Lubricant
US ES
relieves dryness of the eye
prevents further irritation
WARNINGS
DO NOT USE if solution changes color or becomes cloudy
with contact lenses
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 lasts 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,
purified water, sodium chloride. Phosphoric acid and/or sodium
hydroxide may be added to adjust pH.
PRESERVATIVE ADDED: benzalkonium chloride 0.01%
QUESTIONS OR COMMENTS?
CALL 1-800-645-2158
9 am - 5 pm ET, Monday-Friday.
Serious side effects associated with use of this product may be
reported to this number
RUGBY ®
Duluth, GA 30097
HOW SUPPLIED
Product: 50090-0252
NDC: 50090-0252-0 15 mL in a BOTTLE
POLYVINYL ALCOHOL
ARTIFICIAL TEARS
polyvinyl alcohol solution/ drops
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 0 9 0 -0 252(NDC:0 536 -19 70 )
ROUTE OF ADMINISTRATION
OPHTHALMIC
A-S Medication Solutions
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 ) (POLYVINYL ALCOHOL -
UNII:532B59 J9 9 0 )
POLYVINYL ALCOHOL 14 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH