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GoodSense Artifical Tears by Proficient Rx LP

Dosage form: solution/ drops
Ingredients: POLYVINYL ALCOHOL, UNSPECIFIED 0.05g in 1mL, POVIDONE, UNSPECIFIED 0.06g in 1mL
Labeler: Proficient Rx LP
NDC Code: 63187-893

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

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

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

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

GOODSENSE ARTIFICAL TEARS 
polyvinyl alcohol, and povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-893(NDC:50804-017)
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL, UNSPECIFIED (POLYVINYL ALCOHOL) POLYVINYL ALCOHOL, UNSPECIFIED0.05 g  in 1 mL
POVIDONE, UNSPECIFIED (POVIDONE) POVIDONE, UNSPECIFIED0.06 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 
EDETATE DISODIUM 
HYDROCHLORIC ACID 
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 
POTASSIUM CHLORIDE 
WATER 
SODIUM BICARBONATE 
SODIUM CHLORIDE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:63187-893-151 BOTTLE, DROPPER in 1 PACKAGE
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/04/2016
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574RELABEL(63187-893)

 
Proficient Rx LP

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Medically reviewed on Aug 1, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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