GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER- dextran, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution

GoodSense Eye Drops Advanced Relief Moisturizer by

Drug Labeling and Warnings

GoodSense Eye Drops Advanced Relief Moisturizer by is a Otc medication manufactured, distributed, or labeled by Geiss, Derstin & Dunn, Inc., K.C. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Dextran 70.....0.1%

Polyethylene glycol 400.....1%

Povidone.....1%

tetrahydrozoline HCl.....0.05%

PURPOSE

Purposes

Dextran 70.....Lubricant

Polyethylene glycol 400.....Lubricant

Povidone.....Lubricant

Tetrahydrozoline HCl .....Redness reliever

INDICATIONS & USAGE

Uses

• relieves redness of the eye due to minor eye irritations
• as a lubricant to prevent further irritation or to relieve dryness of the eye

WARNINGS

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

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

When using this product

• pupils may become enlarged temporarily
• to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
• if solution changed color or becomes cloudy, do not use
• overuse may produce increased redness of the eye
• remove contact lens before using

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison control Center (1-800-111-1222) right away.

DOSAGE & ADMINISTRATION

Directions

Instill 1 to 2 drops in the affected eye(s) up to 4 times daily.

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER 
dextran, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-130
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	0.1 g  in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	1 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g  in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-130-01	1 in 1 CARTON	01/02/2020
1		15 mL in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/02/2020

Labeler - Geiss, Derstin & Dunn, Inc. (076059836)

Registrant - K.C. Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(50804-130) , pack(50804-130) , label(50804-130)