PUBLIX HIGH PERFORMANCE EYE DROPS- polyethylene glycol 400, propylene glycol liquid

Publix High Performance Eye Drops by

Drug Labeling and Warnings

Publix High Performance Eye Drops by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets, Inc., KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purposes

Lubricant

Lubricant

Use

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

Warnings

For external use only

Do not use

• if this product changes color or becomes cloudy
• if you are sensative to any ingredients in this product

When using this product

• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

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.

Keep out of reach of children.

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

Directions

instill 1 or 2 drops in the affected eye(s) as needed.

Other information

store at 59°-86°F (15°-30°C)

Inactive ingredients

aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol

Publix High Performance Eye Drops 15mL

INGREDIENTS AND APPEARANCE

PUBLIX HIGH PERFORMANCE EYE DROPS 
polyethylene glycol 400, propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-790
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL, UNSPECIFIED - UNII:3WJQ0SDW1A)	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

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BORIC ACID (UNII: R57ZHV85D4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-790-01	1 in 1 BOX	01/01/2020
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	01/01/2020

Labeler - Publix Super Markets, Inc. (006922009)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(56062-790) , pack(56062-790) , label(56062-790)