CorneaCare Recover for dry eyes 10mL (PLD)

CorneaCare Recover for dry eyes by

Drug Labeling and Warnings

CorneaCare Recover for dry eyes by is a Otc medication manufactured, distributed, or labeled by CorneaCare Inc., KC Pharmaceuticals, Inc., Avizor, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CORNEACARE RECOVER FOR DRY EYES- glycerin, povidone solution/ drops 
CorneaCare Inc.

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CorneaCare Recover for dry eyes 10mL (PLD)

Active ingredient

Glycerin 0.63%

Povidone 0.25%

Purpose

Lubricant

Lubricant

Uses

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

Warnings

For external use only

Do no use

• if solution changes color or becomes cloudy
• if tamper evident ring is broken or missing

When using this product

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

Stop use and ask a doctor if

• you experience eye pain, changes in vision, continued redness or irritation of the eye
• condition worsens or persists for more than 72 hours

Keep out of reach of children.

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

Directions

• remove tamper evident ring, then remove cap
• tip bottle at a downward angle or upside down (to deliver drop to eye)
• squeeze bottle to instill 1 or 2 drops in the affected eye(s) as needed
• replace cap after use

Other information

store at 15°-30°C (59°-86°F)

Inactive ingredients

boric acid, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate

Questions or comments?

Call 267-217-3086 or email hello@mycorneacare.com or visit mycorneacare.com/artificial-tear

CorneaCare Recover for Dry Eyes 10mL

CORNEACARE RECOVER FOR DRY EYES 
glycerin, povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82875-001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	0.25 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.63 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BORATE (UNII: 91MBZ8H3QO)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82875-001-01	1 in 1 BOX	01/01/2023	01/01/2023
1		10 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	01/01/2023	01/01/2023

Labeler - CorneaCare Inc. (117781728)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	pack(82875-001) , label(82875-001)

Establishment
Name	Address	ID/FEI	Business Operations
Avizor, S.A.		465588731	manufacture(82875-001)

Revised: 8/2024

Document Id: 1fc31be8-8d8b-a7c7-e063-6294a90aabc0

34390-5

Set id: e3a731a9-ad76-3016-e053-2a95a90a4ec8

Version: 7

Effective Time: 20240815