Leader Lubricant Eye Drops Fast-acting Hydration 15ml (pld)

Leader Lubricant Eye Drops Fast-acting Hydration 15ml (pld)
SPL v5
SPL
SPL Set ID 21811ad8-1aba-db70-e063-6394a90a2bf9
Route
OPHTHALMIC
Published
Effective Date 2024-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Propylene Glycol (0.6 g)
Inactive Ingredients
Peg-6 Sorbitan Oleate Hydrochloric Acid Sodium Hydroxide Benzalkonium Chloride Boric Acid Water Sodium Chloride Castor Oil Edetate Disodium Sodium Borate Potassium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-09-06 Until 2027-10-31

Description

Propylene glycol 0.6%

Purpose

Lubricant


Medication Information

Purpose

Lubricant

Description

Propylene glycol 0.6%

Uses
  • for the 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 exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for use as a lubricant to prevent further irritation or to relieve dryness of the eye
Warnings

For external use only

Directions
  • shake well before using
  • instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use
  • if this product changes color
  • if you are sensitive to any ingredient in this product
Active Ingredient

Propylene glycol 0.6%

Other Information

store at 59-77ºF (15-25ºC)

Inactive Ingredients

benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, **hydrochloric acid, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride, **sodium hydroxide

**May contain these ingredients to adjust pH.

Questions Or Comments?

Call 1-888-527-4276

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
Keep Out of Reach of Children.

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

Leader Lubricant Eye Drops Fast Acting Hydration 15ml


Structured Label Content

Uses
  • for the 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 exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for use as a lubricant to prevent further irritation or to relieve dryness of the eye
Purpose

Lubricant

Warnings

For external use only

Directions
  • shake well before using
  • instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use (Do not use)
  • if this product changes color
  • if you are sensitive to any ingredient in this product
Active Ingredient (Active ingredient)

Propylene glycol 0.6%

Other Information (Other information)

store at 59-77ºF (15-25ºC)

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, **hydrochloric acid, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride, **sodium hydroxide

**May contain these ingredients to adjust pH.

Questions Or Comments? (Questions or comments?)

Call 1-888-527-4276

When Using 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 (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
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Leader Lubricant Eye Drops Fast Acting Hydration 15ml (Leader Lubricant Eye Drops Fast-Acting Hydration 15mL)


Advanced Ingredient Data


Raw Label Data

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