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NDC 63187-0298-15 GOODSENSE ARTIFICIAL TEARS 5; 6 mg/mL; mg/mL Details

GOODSENSE ARTIFICIAL TEARS 5; 6 mg/mL; mg/mL

GOODSENSE ARTIFICIAL TEARS is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE, UNSPECIFIED.

Product Information

NDC	63187-0298
Product ID	63187-298_4f3493eb-ade0-46ca-aef7-92c8afeaa20b
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	GOODSENSE ARTIFICIAL TEARS
Proprietary Name Suffix	n/a
Non-Proprietary Name	POLYVINYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	5; 6
Active Ingredient Units	mg/mL; mg/mL
Substance Name	POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE, UNSPECIFIED
Labeler Name	Proficient Rx LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0298-15 (63187029815)

Pricing Information	N/A
NDC Package Code	63187-298-15
Billing NDC	63187029815
Package	1 BOTTLE in 1 CARTON (63187-298-15) / 15 mL in 1 BOTTLE
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f29c792c-6cb2-449f-b97d-6304a58dec2a Details

SPL UNCLASSIFIED SECTION

Uses

•: temporary relieves burning and irritations due to dryness of the eye(s)
•: protects against further irritation

SPL UNCLASSIFIED SECTION

Warnings

For external use only. Do not use if solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

SPL UNCLASSIFIED SECTION

When using this product

•: remove contact lenses before using
•: do not touch tip of container to any surface to avoid contamination
•: replace cap after each use

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if

•: you feel eye pain
•: changes in vision occur
•: redness or irritation of the eye gets worse or lasts more than 72 hours

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding,

ask a health professional before use.

SPL UNCLASSIFIED SECTION

Keep out of the reach of children.

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

SPL UNCLASSIFIED SECTION

Directions

•: Instill 1 or 2 drops in the affected eye(s) as needed.
•: Store at 15-25C (59-77F).
•: Children under 6 years of age: Ask a doctor

Dosage and Administration

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

Active Ingredient

Each mL contains: Polyvinyl Alcohol 5mg/ml and Povidone 6mg/ml - lubricant

SPL UNCLASSIFIED SECTION

Inactive Ingredients: Benzalkonium Chloride, Dextrose, Disodium Edetate, Potassium Chloride, Purified Water, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate, Sodium Phosphate (Mono- and Dibasic)

PRINCIPAL DISPLAY PANEL

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

GOODSENSE ARTIFICIAL TEARS

polyvinyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-298(NDC:11716-0001)
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	5 mg in 1 mL
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE, UNSPECIFIED	6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE (UNII: SE337SVY37)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-298-15	1 in 1 CARTON	01/01/2019
1		15 mL in 1 BOTTLE; 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	07/22/2010

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-298) , RELABEL(63187-298)

Revised: 1/2021

Document Id: 4f3493eb-ade0-46ca-aef7-92c8afeaa20b

Set id: f29c792c-6cb2-449f-b97d-6304a58dec2a

Version: 3

Effective Time: 20210101

Search by Drug Name or NDC

NDC 63187-0298-15 GOODSENSE ARTIFICIAL TEARS 5; 6 mg/mL; mg/mL Details

GOODSENSE ARTIFICIAL TEARS 5; 6 mg/mL; mg/mL

Product Information

Package

Package Images

NDC 63187-0298-15 (63187029815)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f29c792c-6cb2-449f-b97d-6304a58dec2a Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Dosage and Administration

Active Ingredient

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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