Artificial Tears Lubricant Eye Drops

Manufacturer: Prestige Brands Holdings, Inc.
Effective date: 2024-10-25
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:32:12

Label at a glance#

ProductArtificial Tears Lubricant Eye

Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE

Label structure10 sections

Indications and uses

For the temporary relief of burning & irritations due to dryness of the eye. For use as a protectant against further irritation or to relieve dryness of the eye.

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-877-274-1787

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of burning & irritations due to dryness of the eye.
For use as a protectant against further irritation or to relieve dryness of the eye.

Warnings

WARNINGS SECTION

For external use only

Do not use if

OTC - DO NOT USE SECTION

solution changes color or becomes cloudy.

When using this product:

OTC - WHEN USING SECTION

to avoid contamination, do not touch tip to any surface.
replace cap after using.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

Store at room temperature
Remove contact lenses before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate (mono- and dibasic)

Questions?

OTC - QUESTIONS SECTION

1-877-274-1787

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sterile
Artificial Tears
Lubricant Eye Drops
0.5 FL OZ (15 mL)

Sterile Artificial Tears Lubricant Eye Drops 0.5 FL OZ (15 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
598050	polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic Solution	PSN	5
598050	polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML Ophthalmic Solution	SCD	5
598050	polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic Solution	SY	5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67172-181-01	2020-09-09	C162847	48780-1	9855d018-db23-cd31-e053-dbdaa90ab51a	Artificial Tears Lubricant Eye Drops
67172-181-01	2019-11-27	C162847	48780-1	9855d018-db23-cd31-e053-dbdaa90ab51a	Artificial Tears Lubricant Eye Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67172-181-01	Artificial Tears Lubricant Eye	15 mL in 1 BOTTLE, DROPPER	LIQUID	15		5
67172-181-01	Artificial Tears Lubricant Eye	1 in 1 BOX	LIQUID	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67172-181	ARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL AND POVIDONE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]	5	Legacy NDC, 2 package rows	20241101_4cee7eba-8338-42c5-92ca-71c7df1bbf04.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
POLYVINYL ALCOHOL	ACTIVE INGREDIENT	532B59J990	3
POVIDONES	ACTIVE INGREDIENT	FZ989GH94E	3
POLYVINYL ALCOHOL	ACTIVE MOIETY	532B59J990	3
POVIDONES	ACTIVE MOIETY	FZ989GH94E	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	3
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	3
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	3
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Artificial Tears Lubricant Eye
Polyvinyl Alcohol and Povidone
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE
BENZALKONIUM CHLORIDE
DEXTROSE
EDETATE DISODIUM
POTASSIUM CHLORIDE
WATER
SODIUM BICARBONATE
SODIUM CHLORIDE
SODIUM CITRATE
SODIUM PHOSPHATE, DIBASIC
SODIUM PHOSPHATE, MONOBASIC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67172-181	67172-181-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	ACTIB
POVIDONE	FZ989GH94E	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
DEXTROSE	IY9XDZ35W2	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
POTASSIUM CHLORIDE	660YQ98I10	IACT
WATER	059QF0KO0R	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	IACT
SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 331 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / TOPICAL	14.2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	TABLET / ORAL		231 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GRANULE, EFFERVESCENT / ORAL	267 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SOLUTION / INTRAVENOUS	5.05 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	CAPSULE / ORAL	62 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	INJECTION, SUSPENSION / INTRAVITREAL	0.08 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INFILTRATION		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRAVENOUS	200 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET / SUBLINGUAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAMUSCULAR		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SYRUP / ORAL		70 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / EPIDURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	CONCENTRATE / ORAL	400 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRABURSAL	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVITREAL	10 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	LOZENGE / ORAL		100 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / TOPICAL	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GUM, CHEWING / BUCCAL		240 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / IONTOPHORESIS	0.6 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 34 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION, SOLUTION / INTRAVENOUS	51.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1800 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	POWDER / RESPIRATORY (INHALATION)	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SOLUTION / OPHTHALMIC	0.9 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / TOPICAL	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / IONTOPHORESIS	14.2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b6757f0a-a5fb-41f5-832d-cff789713598			4cee7eba-8338-42c5-92ca-71c7df1bbf04	2024-10-25	Warnings	Exact identifier spl id: b6757f0a-a5fb-41f5-832d-cff789713598 spl set id: 4cee7eba-8338-42c5-92ca-71c7df1bbf04

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.