ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Herunterladen Fachinformation (SPC)
06-03-2018

Wirkstoff:

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

Verfügbar ab:

Preferred Pharmaceuticals, Inc

INN (Internationale Bezeichnung):

POLYVINYL ALCOHOL, UNSPECIFIED

Zusammensetzung:

POLYVINYL ALCOHOL, UNSPECIFIED 14 mg in 1 mL

Verabreichungsweg:

OPHTHALMIC

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

Lubricant

Produktbesonderheiten:

15 mL – 68788-9858-1 Rugby ® Duluth, GA 30097 Relabeled By Preferred Pharmaceuticals, Inc .

Berechtigungsstatus:

OTC monograph final

Fachinformation

                                ARTIFICIAL TEARS- POLYVINYL ALCOHOL SOLUTION/ DROPS
PREFERRED PHARMACEUTICALS, 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._
----------
ARTIFICIAL TEARS SOLUTION DRUG FACTS
ACTIVE INGREDIENT
Polyvinyl Alcohol 1.4%
PURPOS E
Lubricant
US ES
•
•
WARNINGS
•
•
WHEN USING THIS PRODUCT
•
•
STOP USE AND ASK A DOCTOR IF
•
•
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
•
OTHER INFORMATION
•
•
relieves dryness of the eye
prevents further irritation
DO NOT USE if solution changes color or becomes cloudy
with contact lenses
do not touch tip of container to any surface to avoid contamination
replace cap after use
you experience eye pain, changes in vision, continued redness or
irritation of the eye
condition worsens or lasts for more than 72 hours
instill 1 to 2 drops in the affected eye(s) as needed.
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
HOW SUPPLIED
15 mL – 68788-9858-1
RUGBY ®
Duluth, GA 30097
RELABELED BY PREFERRED PHARMACEUTICALS, INC.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
ARTIFICIAL TEARS
polyvinyl alcohol solution/ drops
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 78 8 -9 8 58 (NDC:0 536 -19 70 )
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
Preferred Pharmaceuticals, Inc
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 ) (POLYVINYL
ALCOHOL

                                
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