GOODSENSE ARTIFICAL TEARS- polyvinyl alcohol, and 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:

NuCare Pharmaceuticals,Inc.

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

Uses - For the temporary relief of burning & irritation due to dryness of the eye - For use as a protectant against further irritation or to relieve dryness of the eye Do not use - if solution changes color or becomes cloudy. Stop use and ask a doctor if - you experience eye pain - you experience changes in vision - you experience continued redness or irritation of the eye - the condition worsens - symptoms last for more than 72 hours Directions - Instill 1 or 2 drops in the affected eye(s) as needed. - store at room temperature - remove contact lenses before using

Authorization status:

OTC monograph final

Summary of Product characteristics

GOODSENSE ARTIFICAL TEARS- POLYVINYL ALCOHOL, AND POVIDONE SOLUTION/
DROPS
NUCARE 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._
----------
ACTIVE INGREDIENTS PURPOSE
Polyvinyl alcohol 0.5%............................Lubricant
Povidone 0.6%......................................Lubricant
US ES
For the temporary relief of burning & irritation due to dryness of the
eye
For use as a protectant against further irritation or to relieve
dryness of the eye
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE
if solution changes color or becomes cloudy.
WHEN USING THIS PRODUCT
to avoid contamination, do not touch tip to any surface
replace cap after using
STOP USE AND ASK A DOCTOR IF
you experience eye pain
you experience changes in vision
you experience continued redness or irritation of the eye
the condition worsens
symptoms last 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 or 2 drops in the affected eye(s) as needed.
store at room temperature
remove contact lenses before using
INACTIVE INGREDIENTS
benzlkonium chloride, dibasic sodium phosphate hydrate, edetate
disodium, glucose, hydrochloric acid,
monobasic sodium phosphate, potassium chloride, purified water, sodium
bicarbonate, sodium chloride,
sodium citrate hydrate, sodium hydroxide
DISTRIBUTED BY:
Geiss, Destin & Dunn, Inc.
Peachtree, City, GA 30269
www.valuelabels.com
1-866-696-0957
Made in Korea
Made in Korea
GOODSENSE ARTIFICAL TEARS
polyvinyl alcohol, and povidone solution/ drops
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 0 71-40 9 5(NDC:50 8 0 4-0 17)
ROUTE OF ADMINISTRATION
OPHTHALMIC
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 )
POLY