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NDC 13985-0601-15 Artificial Tears 14 mg/mL Details

Artificial Tears 14 mg/mL

Artificial Tears is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by MWI. The primary component is POLYVINYL ALCOHOL, UNSPECIFIED.

Product Information

NDC	13985-0601
Product ID	13985-601_3f0ac098-2e15-4967-a9c6-e061e4388755
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Artificial Tears
Proprietary Name Suffix	n/a
Non-Proprietary Name	Polyvinyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	14
Active Ingredient Units	mg/mL
Substance Name	POLYVINYL ALCOHOL, UNSPECIFIED
Labeler Name	MWI
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2023-12-31

Package

Package Images

NDC 13985-0601-15 (13985060115)

Pricing Information	N/A
NDC Package Code	13985-601-15
Billing NDC	13985060115
Package	1 BOTTLE, DROPPER in 1 CARTON (13985-601-15) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2015-03-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b6bf402a-fe57-4998-b85e-a262c25e745a Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Eye lubricant

Uses

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

Warnings

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.

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

Directions

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

Other information

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

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?

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

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

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

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS

polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13985-601
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	14 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)
Sodium Phosphate, Monobasic, Anhydrous (UNII: KH7I04HPUU)
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13985-601-15	1 in 1 CARTON	03/23/2015
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	03/23/2015

Labeler - MWI (019926120)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(13985-601) , ANALYSIS(13985-601) , STERILIZE(13985-601) , PACK(13985-601) , LABEL(13985-601)

Revised: 2/2022

Document Id: 3f0ac098-2e15-4967-a9c6-e061e4388755

Set id: b6bf402a-fe57-4998-b85e-a262c25e745a

Version: 5

Effective Time: 20220208

Search by Drug Name or NDC

NDC 13985-0601-15 Artificial Tears 14 mg/mL Details

Artificial Tears 14 mg/mL

Product Information

Package

Package Images

NDC 13985-0601-15 (13985060115)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b6bf402a-fe57-4998-b85e-a262c25e745a Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions?

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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