GNP EYE DROPS DRY EYE RELIEF- glycerin, hypromellose, polyethylene glycol 400 solution

GNP Eye Drops Dry Eye Relief by

Drug Labeling and Warnings

GNP Eye Drops Dry Eye Relief by is a Otc medication manufactured, distributed, or labeled by AmerisourceBergen, K.C. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Glycerin .....0.2%

Hypromellose.....0.2%

Polyethylene glycol 400.....1%

PURPOSE

Purposes

Glycerin.....Lubricant

Hypromellose.....Lubricant

Polyethylene glycol 400.....Lubricant

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

When using this product

• to avoid contamination
• do not touch tip of container to any surface. Replace cap after usine
• remove contact lenses before 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

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

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

OTHER SAFETY INFORMATION

Other informatioon

store at 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

QUESTIONS

Questions or comments?

Call 1-800-888-527-4276

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GNP EYE DROPS DRY EYE RELIEF 
glycerin, hypromellose, polyethylene glycol 400 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-605
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.2 g  in 100 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	0.2 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-605-05	1 in 1 CARTON	01/04/2020
1		15 mL in 1 BOTTLE, DROPPER; 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	01/04/2020

Labeler - AmerisourceBergen (007914906)

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

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(46122-605) , pack(46122-605) , label(46122-605)