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NDC 13985-0600-03 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 MWI. The primary component is MINERAL OIL; PETROLATUM.

Product Information

NDC	13985-0600
Product ID	13985-600_8f691f7d-e1ce-46e1-9709-316c4cfa95b4
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	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	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 13985-0600-03 (13985060003)

Pricing Information	N/A
NDC Package Code	13985-600-03
Billing NDC	13985060003
Package	1 TUBE in 1 CARTON (13985-600-03) / 3.5 g in 1 TUBE
Marketing Start Date	2015-03-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 63284a57-c93d-47a0-8a0f-c583868f19bc Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

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 13985-600-03

Apexa logo

Artificial Tears STERILE

Ophthalmic Lubricant Ointment

Prevents Irritation and Relieves Dryness of the eye

Can be used at bedtime

AP 704001 Net Weight: 3.5g (1/8 oz)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 13985-600-03

Artificial Tears

Ophthalmic

Lubricant

Ointment

STERILE

Prevents Irritation

and Relieves

Dryness of the eye

Can be used

at bedtime

Apexa logo

AP 704001

Net Weight: 3.5g (1/8 oz)

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:13985-600
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:13985-600-03	1 in 1 CARTON	03/23/2015
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	03/23/2015

Labeler - MWI (019926120)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(13985-600) , ANALYSIS(13985-600) , STERILIZE(13985-600) , PACK(13985-600) , LABEL(13985-600)

Revised: 2/2022

Document Id: 8f691f7d-e1ce-46e1-9709-316c4cfa95b4

Set id: 63284a57-c93d-47a0-8a0f-c583868f19bc

Version: 5

Effective Time: 20220208

Search by Drug Name or NDC

NDC 13985-0600-03 Artificial Tears 150; 830 mg/g; mg/g Details

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

Product Information

Package

Package Images

NDC 13985-0600-03 (13985060003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 63284a57-c93d-47a0-8a0f-c583868f19bc Details

SPL UNCLASSIFIED SECTION

Active ingredients

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredient

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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