Leader Eye Drops Redness Relief (pld)

Leader Eye Drops Redness Relief (pld)
SPL v5
SPL
SPL Set ID aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a
Route
OPHTHALMIC
Published
Effective Date 2021-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.25 g) Naphazoline (0.012 g)
Inactive Ingredients
Water Benzalkonium Chloride Boric Acid Edetate Disodium Sodium Borate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-30 Until 2027-11-30

Description

Glycerin 0.25% Naphazoline hydrochloride 0.012%

Purpose

Glycerin...Lubricant Naphazoline hydrochloride...Redness reliever


Medication Information

Purpose

Glycerin...Lubricant Naphazoline hydrochloride...Redness reliever

Description

Glycerin 0.25% Naphazoline hydrochloride 0.012%

Uses
  • for the relief of redness of the eye due to minor eye irritations
  • for the temporary relief of burning and irritation due to dryness of the eye 
  • for use as a protectant against further irritation or dryness of the eye
Section 51945-4

Purposes

Glycerin...Lubricant

Naphazoline hydrochloride...Redness reliever

Warnings

For external use only

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily

children under 6 years of age:ask a doctor

Do Not Use
  • if solution changes color or becomes cloudy
Other Information
  • store at room temperature
  • remove contact lenses before using
Active Ingredients

Glycerin 0.25%

Naphazoline hydrochloride 0.012%

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

When Using This Product
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
  • overuse may produce increased redness of the eye
  • pupils may become enlarged temporarily
questions Or Comments?

Call  1-888-527-4276

Stop Use and Ask A Doctor If
  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • the 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.

Ask A Doctor Before Use If You Have

narrow angle glaucoma


Structured Label Content

Uses
  • for the relief of redness of the eye due to minor eye irritations
  • for the temporary relief of burning and irritation due to dryness of the eye 
  • for use as a protectant against further irritation or dryness of the eye
Section 51945-4 (51945-4)

Purposes

Glycerin...Lubricant

Naphazoline hydrochloride...Redness reliever

Warnings

For external use only

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily

children under 6 years of age:ask a doctor

Do Not Use (Do not use)
  • if solution changes color or becomes cloudy
Other Information (Other information)
  • store at room temperature
  • remove contact lenses before using
Active Ingredients (Active ingredients)

Glycerin 0.25%

Naphazoline hydrochloride 0.012%

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

When Using This Product (When using this product)
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
  • overuse may produce increased redness of the eye
  • pupils may become enlarged temporarily
questions Or Comments? (Questions or comments?)

Call  1-888-527-4276

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • the condition worsens or persists for 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

narrow angle glaucoma


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)