CAREONE ARTIFICIAL TEARS EYE DROPS 15ML- polyvinyl alcohol, povidone liquid

CareOne Artificial Tears Eye Drops 15mL by

Drug Labeling and Warnings

CareOne Artificial Tears Eye Drops 15mL by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, LLC, KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Polyvinyl Alcohol 0.5%

Povidone 0.6%

Purposes

Lubricant

Lubricant

Uses

Uses

• for use as a protectant against further irritation or to relieve dryness of the eye
• for the temporary relief of discomfort due to minor irritations of the eye, or exposure to wind or sun

Warnings

For external use only

When using this product

• remove contact lens before using
• to avoid contamination, do not touch tip of container to any surface
• replace cap after using. Keep container tightly closed.

Do not use this product if

• solution changes color or becomes cloudy

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

Keep out of the reach of children.

if accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

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

Other information

• store at 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

Call 1-888-527-4276

CareOne Artificial Tears

INGREDIENTS AND APPEARANCE

CAREONE ARTIFICIAL TEARS EYE DROPS 15ML 
polyvinyl alcohol, povidone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-038
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	0.5 g  in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	0.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
DEXTROSE (UNII: IY9XDZ35W2)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-038-01	1 in 1 BOX	10/29/2019
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	10/29/2019

Labeler - Retail Business Services, LLC (967989935)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(72476-038) , pack(72476-038) , label(72476-038)