Ultra Lubricant Eye Drops

Manufacturer: Chain Drug Consortium | Akorn, Inc. | Akorn, Inc
Effective date: 2015-10-23
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:30:14

Label at a glance#

ProductUltra Lubricant Eye Drops

Active ingredientPolyethylene Glycol 400, Propylene Glycol

Label structure11 sections

Indications and uses

For the temporary relief of burning and irritation due to dryness of the eye.

Dosage and administration

shake well before using 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 ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of burning and irritation due to dryness of the eye.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

if this product changes color or becomes cloudy
if you are sensitive to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

do not touch tip of container to any surface to avoid contamination
replace cap after each use

Stop use and ask a doctor if

OTC - STOP USE SECTION

you feel eye pain
changes in vision occur
redness or irritation of the eye(s) gets worse, persists or lasts 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

shake well before using
instill 1 or 2 drops in the affected eye(s) as needed.

Other information

SPL UNCLASSIFIED SECTION

store at 20° to 25°C (68°to77°F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Sorbitol solution, Boric Acid, 2-amino-2-methyl-1-propanol, Hypromellose USP, Sodium Chloride, Potassium Chloride. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH;

Preservative

SPL UNCLASSIFIED SECTION

Benzalkonium Chloride.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-932-5676

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 68016-402-00

Premier

Value^® Logo

Ultra Lubricant

Eye Drops

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

10 mL (0.34 FL OZ) STERILE

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 68016-402-00

*COMPARE TO THE

ACTIVE INGREDIENT

IN SYSTANE^® ULTRA

Premier

Value^® Logo

Ultra

Lubricant

Eye Drops

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Lubricant eye drops for irritated eyes
Long lasting protection
Fast relief

10 mL (0.34 FL OZ)

STERILE PV Brand Logo

Principal Display Panel Text for Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68016-402-00	2020-10-21	C162847	48780-1	9d75b9d0-d222-f424-e053-dadaa90a57ce	9ca6cfb5-e942-4907-be8e-a24e8895d6cf
68016-402-00	2020-01-31	C162847	48780-1	9d75b9d0-d222-f424-e053-dadaa90a57ce	9ca6cfb5-e942-4907-be8e-a24e8895d6cf

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-402-00	ML - Milliliter	68016-402	543c0507-b71f-4ef3-bda9-5cfbc47058bb	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Polyethylene Glycol 400	ACTIVE INGREDIENT	B697894SGQ	2
Propylene Glycol	ACTIVE INGREDIENT	6DC9Q167V3	2
Polyethylene Glycol 400	ACTIVE MOIETY	B697894SGQ	2
Propylene Glycol	ACTIVE MOIETY	6DC9Q167V3	2
Aminomethylpropanol	INACTIVE INGREDIENT	LU49E6626Q	2
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	2
Boric Acid	INACTIVE INGREDIENT	R57ZHV85D4	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	2
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	2
Potassium Chloride	INACTIVE INGREDIENT	660YQ98I10	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	2
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Ultra Lubricant Eye Drops
Polyethylene Glycol 400 and Propylene Glycol
Polyethylene Glycol 400
Propylene Glycol
Water
Sorbitol
Boric Acid
Aminomethylpropanol
Hypromelloses
Sodium Chloride
Potassium Chloride
Hydrochloric Acid
Sodium Hydroxide
Benzalkonium Chloride

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68016-402	68016-402-00

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
Polyethylene Glycol 400	B697894SGQ	ACTIB
Propylene Glycol	6DC9Q167V3	ACTIB
Water	059QF0KO0R	IACT
Sorbitol	506T60A25R	IACT
Boric Acid	R57ZHV85D4	IACT
Aminomethylpropanol	LU49E6626Q	IACT
Hypromelloses	3NXW29V3WO	IACT
Sodium Chloride	451W47IQ8X	IACT
Potassium Chloride	660YQ98I10	IACT
Hydrochloric Acid	QTT17582CB	IACT
Sodium Hydroxide	55X04QC32I	IACT
Benzalkonium Chloride	F5UM2KM3W7	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 10 · 588 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / DENTAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACARDIAC		70 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SPRAY, METERED / NASAL		36 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	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 Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / RESPIRATORY (INHALATION)	8 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / EXTRACORPOREAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / ORAL	2 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 148 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
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION / INTRATYMPANIC		1 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
Potassium Chloride	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION / OPHTHALMIC	0.22 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTABLE, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %w/v		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 Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUPPOSITORY / RECTAL		140 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, EMULSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 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
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SYSTEM / TOPICAL		54 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVITREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVASCULAR	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	136.55 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	CREAM / TOPICAL		38 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
Boric Acid	BORIC ACID	R57ZHV85D4	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CREAM, AUGMENTED / TOPICAL		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	LIQUID / ORAL	4.46 mg/1ml		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, EMULSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CONCENTRATE / ORAL	10 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INFILTRATION	0.37 %w/v		Exact identifier — unii candidate 148 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
13c363f7-1600-4772-9a08-0e7a39aa332d			9ca6cfb5-e942-4907-be8e-a24e8895d6cf	2020-10-21	Warnings	Exact identifier spl set id: 9ca6cfb5-e942-4907-be8e-a24e8895d6cf

Reported adverse events (FAERS/openFDA)#

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