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NDC 50804-0020-01 Good Sense Lubricant Eye Drops .4; .3 g/100mL; g/100mL Details

Good Sense Lubricant Eye Drops .4; .3 g/100mL; g/100mL

Good Sense Lubricant Eye Drops is a OPHTHALMIC LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Good Sense. The primary component is POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL.

Product Information

NDC	50804-0020
Product ID	50804-020_12cd7255-5fcd-4c6d-9981-0e67f99dda40
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	Good Sense Lubricant Eye Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	Polyethylene glycol 400, propylene glycol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	OPHTHALMIC
Active Ingredient Strength	.4; .3
Active Ingredient Units	g/100mL; g/100mL
Substance Name	POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Labeler Name	Good Sense
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 50804-0020-01 (50804002001)

Pricing Information	N/A
NDC Package Code	50804-020-01
Billing NDC	50804002001
Package	30 AMPULE in 1 BOX (50804-020-01) / .4 mL in 1 AMPULE
Marketing Start Date	2019-05-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 58ac748d-6f66-43f1-b8c2-f93148f8b5d0 Details

SPL UNCLASSIFIED SECTION

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

SPL UNCLASSIFIED SECTION

Purpose

Polyethylene glycol 400............. Lubricant

Propylene glycol............ Lubricant

SPL UNCLASSIFIED SECTION

Uses

• for the temporary relief of burning and irritation due to dryness of the eye

SPL UNCLASSIFIED SECTION

Warnings

For external use only

Do not use

• if this solution changes color or becomes cloudy

• if you are sensitive to any ingredient in this product

When using this product

do not touch tip of container to any surface to avoid contamination
do not reuse
once opened, discard

Stop use and ask a doctor if

• you feel eye pain

• changes in vision occur

• redness or irritation of the eye(s) gets worse or lasts more than 72 hours

If pregnant or breast-feeding, ask a health professional before use.

SPL UNCLASSIFIED SECTION

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

SPL UNCLASSIFIED SECTION

Directions

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

SPL UNCLASSIFIED SECTION

Other information

store at 15°-25°C (59°-77°F)
use only if single-use container is intact
use before expiration date marked on container
RETAIN THIS CARTON FOR FUTURE REFERENCE

SPL UNCLASSIFIED SECTION

Inactive ingredients

boric acid, hypromellose, potassium chloride, purified water, sodium chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOOD SENSE LUBRICANT EYE DROPS

polyethylene glycol 400, propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-020
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	0.4 g in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50804-020-01	30 in 1 BOX	05/17/2019
1		0.4 mL in 1 AMPULE; 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	05/17/2019

Labeler - Good Sense (076059836)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	manufacture(50804-020) , pack(50804-020) , label(50804-020)

Revised: 5/2019

Document Id: 12cd7255-5fcd-4c6d-9981-0e67f99dda40

Set id: 58ac748d-6f66-43f1-b8c2-f93148f8b5d0

Version: 1

Effective Time: 20190518

Search by Drug Name or NDC

NDC 50804-0020-01 Good Sense Lubricant Eye Drops .4; .3 g/100mL; g/100mL Details

Good Sense Lubricant Eye Drops .4; .3 g/100mL; g/100mL

Product Information

Package

Package Images

NDC 50804-0020-01 (50804002001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 58ac748d-6f66-43f1-b8c2-f93148f8b5d0 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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