GOODSENSE ARTIFICIAL TEARS- polyvinyl alcohol solution

GOODSENSE ARTIFICIAL TEARS by

Drug Labeling and Warnings

GOODSENSE ARTIFICIAL TEARS by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Uses

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

WARNINGS

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

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

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
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

GOODSENSE ARTIFICIAL TEARS 
polyvinyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-298(NDC:11716-0001)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	5 mg  in 1 mL
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE, UNSPECIFIED	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE (UNII: SE337SVY37)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-298-15	1 in 1 CARTON	01/01/2019
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/22/2010

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079502574	REPACK(63187-298) , RELABEL(63187-298)