AVENOVA LUBRICANT EYE DROPS HIGH PERFORMANCE- polyethylene glycol 400, propylene glycol solution/ drops

Avenova Lubricant Eye Drops High Performance by

Drug Labeling and Warnings

Avenova Lubricant Eye Drops High Performance by is a Otc medication manufactured, distributed, or labeled by NovaBay Pharmaceuticals, 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 sensitive to any ingredient 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 to 2 drops in the affected eye(s) as needed

Other information

store at 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

Call 1-800-890-0329

Email: sales@avenova.com

Avenova Lubricant Eye Drops High Performance 15mL twin pk

INGREDIENTS AND APPEARANCE

AVENOVA LUBRICANT EYE DROPS HIGH PERFORMANCE 
polyethylene glycol 400, propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81963-101
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81963-101-10	2 in 1 BOX	09/28/2021
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 Drug	M018	09/28/2021

Labeler - NovaBay Pharmaceuticals, Inc. (191505192)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(81963-101) , pack(81963-101) , label(81963-101)