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NDC 17478-0062-35 Artificial Tears 150; 830 mg/g; mg/g Details

Artificial Tears 150; 830 mg/g; mg/g

Artificial Tears is a OPHTHALMIC OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. The primary component is MINERAL OIL; PETROLATUM.

Product Information

NDC	17478-0062
Product ID	17478-062_bc0d783a-a7df-47b6-91ec-30c45775afe5
Associated GPIs	86209902904220
GCN Sequence Number	063178
GCN Sequence Number Description	mineral oil/petrolatum,white OINT. (G) 15 %-83 % OPHTHALMIC
HIC3	Q6Y
HIC3 Description	EYE PREPARATIONS, MISCELLANEOUS (OTC)
GCN	98935
HICL Sequence Number	002215
HICL Sequence Number Description	MINERAL OIL/PETROLATUM,WHITE
Brand/Generic	Brand
Proprietary Name	Artificial Tears
Proprietary Name Suffix	n/a
Non-Proprietary Name	Mineral Oil and Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	OPHTHALMIC
Active Ingredient Strength	150; 830
Active Ingredient Units	mg/g; mg/g
Substance Name	MINERAL OIL; PETROLATUM
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 17478-0062-35 (17478006235)

Pricing Information
NDC Package Code	17478-062-35
Billing NDC	17478006235
Package	1 TUBE in 1 CARTON (17478-062-35) / 3.5 g in 1 TUBE
Marketing Start Date	1990-09-01
NDC Exclude Flag	N
Price Per Unit	1.41265
Pricing Unit	GM
Effective Date	2022-10-19
NDC Description	ARTIFICIAL TEARS EYE OINTMENT
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 c7479297-1ebc-4752-93b5-e4ad7f8c47f5 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Mineral Oil 15%

White Petrolatum 83%

Purpose

Eye lubricant

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eyes.

Warnings

For external use only.
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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.

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.
See crimp for Control Number and Expiration Date.
RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredient

Lanolin 2%

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-062-35 Akorn Logo

Artificial Tears OINTMENT

Lubricant Eye Ointment

Sterile

FOR OPHTHALMIC USE ONLY Net Wt. 3.5 g (1/8oz.)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-062-35

3.5 g

Artificial

Tears

OINTMENT

Lubricant

Eye Ointment

Can Be Used at Bedtime

Sterile

Net Wt. 3.5 g (1/8oz.)

Principal Display Panel Text for Carton Label

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS

mineral oil and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17478-062
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	150 mg in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	830 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Lanolin (UNII: 7EV65EAW6H)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17478-062-35	1 in 1 CARTON	09/01/1990
1		3.5 g in 1 TUBE; 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	09/01/1990

Labeler - Akorn (117696770)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(17478-062) , ANALYSIS(17478-062) , STERILIZE(17478-062) , PACK(17478-062) , LABEL(17478-062)

Revised: 1/2022

Document Id: bc0d783a-a7df-47b6-91ec-30c45775afe5

Set id: c7479297-1ebc-4752-93b5-e4ad7f8c47f5

Version: 5

Effective Time: 20220121

Search by Drug Name or NDC

NDC 17478-0062-35 Artificial Tears 150; 830 mg/g; mg/g Details

Artificial Tears 150; 830 mg/g; mg/g

Product Information

Package

Package Images

NDC 17478-0062-35 (17478006235)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c7479297-1ebc-4752-93b5-e4ad7f8c47f5 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredient

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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