MedPath

Dry eye relief

Sterile Dry eye Relief

Approved
Approval ID

f8da3af5-9172-4023-be82-0fd5bd891616

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 12, 2025

Manufacturers
FDA

CARDINAL HEALTH 110, LLC. DBA LEADER

DUNS: 063997360

Products 1

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

polyethylene glycol and propylene glycol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70000-0088
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
polyethylene glycol and propylene glycol
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 12, 2025
FDA Product Classification

INGREDIENTS (15)

POLYETHYLENE GLYCOL 400Active
Quantity: 4 mg in 1 mL
Code: B697894SGQ
Classification: ACTIB
PROPYLENE GLYCOLActive
Quantity: 3 mg in 1 mL
Code: 6DC9Q167V3
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CHLORITEInactive
Code: G538EBV4VF
Classification: IACT
ZINC CHLORIDEInactive
Code: 86Q357L16B
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/12/2025

Principal Display Panel

LEADER®

NDC 70000-0088-1

Sterile

Dry Eye

Relief

Polyethylene Glycol 400, 0.4%

Propylene Glycol, 0.3%

Lubricant

Moisturizes Dry Eyes

Actual Bottle Size on Side Panel

COMPARE TO SYSTANE® LUBRICANT GEL DROPS active ingredients*

100% Money Back Guarantee

0.33 FL OZ (10 mL)

0.4% / 0.3% carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/12/2025

Uses

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

for use as a protectant against further irritation or to relieve dryness of the eye

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/12/2025

Active Ingredients

Purpose

Polyethylene Glycol 400 0.4%

Lubricant

Propylene Glycol 0.3%

Lubricant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/12/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/12/2025

Do not use

if this product changes color or becomes cloudy

if you are sensitive to any ingredient in this product

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/12/2025

Directions

shake well before using

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/12/2025

When using this product

do not touch tip of container to any surface to avoid contamination

replace cap after each use

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/12/2025

Stop use and ask a doctor ifyou experience any of the following:

you feel eye pain

changes in vision

continued redness or irritation of the eye

condition worsens or persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/12/2025

**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/12/2025

Inactive ingredients

boric acid, edetate disodium , potassium chloride, mangnesium chloride , sodium chloride, sodium borate , purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/12/2025

Other information

store at room temperature

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/12/2025

.

TAMPER EVIDENT

Do not use if tape seals on carton top and bottom flaps are damaged or missing.

*This product is not manufactured or distributed by Alcon, Inc., owner of the registered trademark Systane® Lubricant Gel Drops.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-9313

Made in India

100% Money back Guarantee

Return to place of purchase if not satisfied.

Code: MH/DRUGS/28-KD/283

CIN 5698394

REV. 2/21

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