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Leader Restorative Formula Lubricant Eye Drops

Leader Restorative Formula Lubricant Eye Drops (PLD)

Approved
Approval ID

87fef7e4-e5a8-4aad-94d2-f80f34826d97

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

Cardinal Health

DUNS: 063997360

Products 1

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

propylene glycol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70000-0013
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
propylene glycol
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (10)

BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PEG-6 SORBITAN OLEATEInactive
Code: 58O7V09UCI
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
PROPYLENE GLYCOLActive
Quantity: 0.6 g in 100 mL
Code: 6DC9Q167V3
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/30/2019

carton-twin pack

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/30/2019

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/30/2019

Active ingredients

Propylene glycol....0.6%

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 4/30/2019

Other information

  • Store at room temperature.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/30/2019

Purpose

Propylene glycol............ Lubricant

WARNINGS SECTION

LOINC: 34071-1Updated: 4/30/2019

Warnings
For external use only

Do not use
• if this product changes color
• 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 experience eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/30/2019

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/30/2019

Directions

  • Shake well before using.
  • Instill 1 or 2 drops in the affected eye(s) as needed

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/30/2019

**Inactive ingredients**

Benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/30/2019

Questions & comments?

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