Gnp Eye Drops Maximum Redness Relief (pld)

Gnp Eye Drops Maximum Redness Relief (pld)
SPL v3
SPL
SPL Set ID 9b594424-08ad-c006-e053-2a95a90af91e
Route
OPHTHALMIC
Published
Effective Date 2020-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naphazoline (0.03 g) Glycerin (0.5 g)
Inactive Ingredients
Boric Acid Water Benzalkonium Chloride Edetic Acid Sodium Borate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-05

Description

Active ingredients Glycerin.....0.5% Naphazoline HCl...0.03%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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
Dosage and Administration

Directions

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

Description

Active ingredients Glycerin.....0.5% Naphazoline HCl...0.03%

Section 50565-1

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

Section 50566-9

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
Section 50567-7

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
  • overuse may producte increased redness of the eye
  • pupils may become enlarged temporarily
Section 50569-3

Ask a doctor before use if you have narrow angle glaucoma

Section 50570-1

Do not use if solution changes color or becomes cloudy

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-866-627-4278

Section 55105-1

Purpose

Glycerin.....Lubricant

Naphazoline HCl...Redness reliever

Section 55106-9

Active ingredients

Glycerin.....0.5%

Naphazoline HCl...0.03%

Section 60561-8

Other information

  • store at room temperature
  • remove contact lenses before using

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Directions

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
  • overuse may producte increased redness of the eye
  • pupils may become enlarged temporarily
Section 50569-3 (50569-3)

Ask a doctor before use if you have narrow angle glaucoma

Section 50570-1 (50570-1)

Do not use if solution changes color or becomes cloudy

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-866-627-4278

Section 55105-1 (55105-1)

Purpose

Glycerin.....Lubricant

Naphazoline HCl...Redness reliever

Section 55106-9 (55106-9)

Active ingredients

Glycerin.....0.5%

Naphazoline HCl...0.03%

Section 60561-8 (60561-8)

Other information

  • store at room temperature
  • remove contact lenses before using

Advanced Ingredient Data


Raw Label Data

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