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NDC 17478-0060-12 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 Akorn. The primary component is POLYVINYL ALCOHOL, UNSPECIFIED.

Product Information

NDC	17478-0060
Product ID	17478-060_05d14c58-ab14-4ccf-bad4-97b916ed55f3
Associated GPIs	86200050002030
GCN Sequence Number	007936
GCN Sequence Number Description	polyvinyl alcohol DROPS 1.4 % OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	33422
HICL Sequence Number	005225
HICL Sequence Number Description	POLYVINYL ALCOHOL
Brand/Generic	Brand
Proprietary Name	Artificial Tears
Proprietary Name Suffix	n/a
Non-Proprietary Name	Polyvinyl Alcohol, Unspecified
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	Akorn
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 17478-0060-12 (17478006012)

Pricing Information
NDC Package Code	17478-060-12
Billing NDC	17478006012
Package	1 BOTTLE, DROPPER in 1 CARTON (17478-060-12) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	1998-03-01
NDC Exclude Flag	N
Price Per Unit	0.33505
Pricing Unit	ML
Effective Date	2022-10-19
NDC Description	ARTIFICIAL TEARS 1.4% DROPS
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 736f9577-d8ff-45c7-8205-dfdb7193492f 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, weekdays, 7:00 AM - 5:30 PM CST

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-060-12

Artificial

Tears

Solution

Polyvinyl

Alcohol 1.4%

Lubricant

Eye Drops

Sterile

15 mL (0.5 fl. oz.)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-060-12

15 mL

Artificial

Tears

Solution

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops

Prevents Irritation and Relieves

Dryness of the Eye

Sterile

15 mL (0.5 fl. oz.)

Principal Display Panel Text for Carton Label

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS

polyvinyl alcohol, unspecified solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17478-060
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:17478-060-12	1 in 1 CARTON	03/01/1998
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	03/01/1998

Labeler - Akorn (117696770)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(17478-060) , ANALYSIS(17478-060) , STERILIZE(17478-060) , PACK(17478-060) , LABEL(17478-060)

Revised: 1/2022

Document Id: 05d14c58-ab14-4ccf-bad4-97b916ed55f3

Set id: 736f9577-d8ff-45c7-8205-dfdb7193492f

Version: 5

Effective Time: 20220121

Search by Drug Name or NDC

NDC 17478-0060-12 Artificial Tears 14 mg/mL Details

Artificial Tears 14 mg/mL

Product Information

Package

Package Images

NDC 17478-0060-12 (17478006012)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 736f9577-d8ff-45c7-8205-dfdb7193492f Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions?

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

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