MedPath

Ripple

Ripple Eye Lubricant Drops

Approved
Approval ID

3b5ba197-d501-681e-e063-6294a90aefb5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 2, 2025

Manufacturers
FDA

CorneaCare Inc

DUNS: 117781728

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

glycerin, povidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82875-003
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
glycerin, povidone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 2, 2025
FDA Product Classification

INGREDIENTS (10)

MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
GLYCERINActive
Quantity: 0.63 g in 100 mL
Code: PDC6A3C0OX
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
POVIDONEActive
Quantity: 0.25 g in 100 mL
Code: FZ989GH94E
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/2/2025

![Ripple Eye Lubricant - Outer box](/dailymed/image.cfm?name=Ripple- corneacare-carton.jpg&id=890523)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/2/2025

Uses

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

• For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

• For use as a protectant against irritation or to relieve dryness of the eye.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/2/2025

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center
(1-800-222-1222)right away. ►

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/2/2025

Eye Lubricant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/2/2025

Warnings
For external use only
Do not use
■If solution changes color or becomes cloudy.
■lf 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 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/2/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/2/2025

Glycerin 0.63%
Povidone 0.25%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/2/2025

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

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Ripple - FDA Drug Approval Details