GOOD SENSE ARTIFICIAL TEARS by DIRECT RX ARTIFICIAL TEAR DROPS

GOOD SENSE ARTIFICIAL TEARS by

Drug Labeling and Warnings

GOOD SENSE ARTIFICIAL TEARS by is a Otc medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GOOD SENSE ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution 
DIRECT RX

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ARTIFICIAL TEAR DROPS

Active ingredients

Polyvinyl alcohol.....0.5%

Povidone......0.6%

Purposes

Polyvinyl alcohol ...Eye lubricant

Povidone ...Eye lubricant

Uses

for use as a protectant against further irritation or to relieve dryness of the eye
for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

Stop use and ask a doctor if you experience

eye pain
changes in vision
continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

When using this product

to avoid contamination, do not touch tip of container to any surface
replace cap after using. Keep container tightly closed
remove contact lens before using

Directions

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

Other information

Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at 15º-30º C (59º-86ºF)

Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic

GOOD SENSE ARTIFICIAL TEARS 
polyvinyl alcohol, povidone solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72189-224(NDC: 50804-110)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	0.6 g  in 100 mL
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-224-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2021	10/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	05/26/2021	10/09/2023

Labeler - DIRECT RX (079254320)

Registrant - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	relabel(72189-224)

Revised: 10/2023

Document Id: 074a116a-e4c2-882c-e063-6394a90a58c0

34390-5

Set id: c33dd049-c1d4-176b-e053-2995a90a3c2b

Version: 3

Effective Time: 20231009