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GOODSENSE ARTIFICIAL TEARS by Proficient Rx LP

Medically reviewed on Feb 1, 2018

Dosage form: solution
Ingredients: POLYVINYL ALCOHOL 5mg in 1mL, POVIDONES 6mg in 1mL
Labeler: Proficient Rx LP
NDC Code: 63187-298

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.

Drug Facts

Uses

temporary relieves burning and irritations due to dryness of the eye(s)
protects against further irritation

Warnings

For external use only.  Do not use if solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

When using this product

remove contact lenses before using
do not touch tip of container to any surface to avoid contamination
replace cap after each use

Stop use and ask a doctor if

you feel eye pain
changes in vision occur
redness or irritation of the eye gets worse or lasts more than 72 hours

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the 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 15-25C (59-77F).
Children under 6 years of age: Ask a doctor

Dosage and Administration
Instill 1 or 2 drops in the affected eye(s) as needed.

Active Ingredient

Each mL contains: Polyvinyl Alcohol 5mg/ml and Povidone 6mg/ml - lubricant

Inactive Ingredients: Benzalkonium Chloride, Dextrose, Disodium Edetate, Potassium Chloride, Purified Water, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate, Sodium Phosphate (Mono- and Dibasic)

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

GOODSENSE ARTIFICIAL TEARS 
polyvinyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-298(NDC:11716-0001)
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (POLYVINYL ALCOHOL) POLYVINYL ALCOHOL5 mg  in 1 mL
POVIDONES (POVIDONE) POVIDONES6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
DEXTROSE, UNSPECIFIED FORM 
EDETATE DISODIUM 
POTASSIUM CHLORIDE 
WATER 
SODIUM BICARBONATE 
SODIUM CHLORIDE 
SODIUM CITRATE, UNSPECIFIED FORM 
SODIUM PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:63187-298-151 BOTTLE in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/22/2010
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-298), RELABEL(63187-298)

 
Proficient Rx LP

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Further information

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

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