Artificial Tears

Manufacturer: MWI | Akorn Operating Company LLC | Akorn
Effective date: 2022-02-08
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:48:08

Label at a glance#

ProductArtificial Tears

Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED

Label structure11 sections

Indications and uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-800-932-5676

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl Alcohol 1.4%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Warnings

WARNINGS SECTION

Do not use if imprinted seal on the bottle neck is broken or missing.
Do not use if solution changes color or becomes cloudy.
To avoid contamination, do not touch tip of container to any surface.
Replace cap after using.

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

Store at 20° to 25°C (68° to 77°F)
[see USP Controlled Room Temperature].
Store away from heat.
Protect from freezing.
Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-932-5676.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 13985-601-15

Artificial Tears

Solution

Polyvinyl Alcohol 1.4%

STERILE

Lubricant Eye Drops

Apexa logo

AP 704002 15 mL

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 13985-601-15

Artificial Tears

Solution

Polyvinyl Alcohol 1.4%

STERILE

Lubricant Eye Drops

Prevents Irritation

and Relieves

Dryness of the eye

Apexa logo

AP 704002 15 mL

Principal Display Panel Text for Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
142004	polyvinyl alcohol 1.4 % Ophthalmic Solution	PSN	5
142004	polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution	SCD	5
142004	polyvinyl alcohol 1.4 % Ophthalmic Solution	SY	5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13985-601-15	2024-01-30	C162847	48780-1	1030e365-6556-111a-e063-dadaa90a10e2	b6bf402a-fe57-4998-b85e-a262c25e745a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13985-601-15	Artificial Tears	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		5
13985-601-15	Artificial Tears	1 in 1 CARTON	SOLUTION/ DROPS	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13985-601	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	5	Legacy NDC, 2 package rows	20220209_b6bf402a-fe57-4998-b85e-a262c25e745a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Polyvinyl Alcohol	ACTIVE INGREDIENT	532B59J990	1
Polyvinyl Alcohol	ACTIVE MOIETY	532B59J990	1
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	1
Sodium Phosphate, Monobasic, Anhydrous	INACTIVE INGREDIENT	KH7I04HPUU	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Artificial Tears
Polyvinyl Alcohol
POLYVINYL ALCOHOL, UNSPECIFIED
Benzalkonium Chloride
Edetate Disodium
Sodium Chloride
Sodium Phosphate, Dibasic, Anhydrous
Sodium Phosphate, Monobasic, Anhydrous
Water
Sodium Hydroxide
Hydrochloric Acid

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13985-601	13985-601-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	ACTIB
Benzalkonium Chloride	F5UM2KM3W7	IACT
Edetate Disodium	7FLD91C86K	IACT
Sodium Chloride	451W47IQ8X	IACT
Sodium Phosphate, Dibasic, Anhydrous	22ADO53M6F	IACT
Sodium Phosphate, Monobasic, Anhydrous	KH7I04HPUU	IACT
Water	059QF0KO0R	IACT
Sodium Hydroxide	55X04QC32I	IACT
Hydrochloric Acid	QTT17582CB	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 11 · 646 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRAMUSCULAR		1751 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / EXTRACORPOREAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRAMUSCULAR		1037 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / IONTOPHORESIS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, EMULSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, EMULSION / INTRAVENOUS	0.28 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	TABLET, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	AEROSOL, FOAM / TOPICAL	0.09 %w/w		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	GEL / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SHAMPOO / TOPICAL		3 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	139.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRAVENOUS		1037 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / INTRAMUSCULAR		36 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TROCHE / ORAL	28 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	EMULSION / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SPRAY, METERED / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	CAPSULE, LIQUID FILLED / ORAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SUSPENSION / OPHTHALMIC	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SYRUP / ORAL	71 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / DENTAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, SUSPENSION / INTRASYNOVIAL		10 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SYRUP / ORAL		70 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION / INTRAVENOUS	12.8 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	FILM, SOLUBLE / ORAL	0.05 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / INTRAVENOUS		381 mg	Exact identifier — unii candidate 48 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
3f0ac098-2e15-4967-a9c6-e061e4388755			b6bf402a-fe57-4998-b85e-a262c25e745a	2022-02-08	Warnings	Exact identifier spl id: 3f0ac098-2e15-4967-a9c6-e061e4388755 spl set id: b6bf402a-fe57-4998-b85e-a262c25e745a

Reported adverse events (FAERS/openFDA)#

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