Quality Choice Eye Drops Irritation Relief (pld)

Quality Choice Eye Drops Irritation Relief (pld)
SPL v2
SPL
SPL Set ID 1f682079-6e91-e14b-e063-6394a90a3f12
Route
OPHTHALMIC
Published
Effective Date 2024-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetrahydrozoline (0.05 g) Zinc Cation (0.25 g)
Inactive Ingredients
Water Benzalkonium Chloride Boric Acid Edetic Acid Sodium Chloride Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-11

Description

Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%

Purpose

Redness reliever Astringent


Medication Information

Purpose

Redness reliever Astringent

Description

Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%

Use

  • for temporary relief of discomfort and redness of the eye due to minor eye irritation
Purposes

Redness reliever

Astringent

Warnings

For external use only

Directions

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

Other Information

store at 15º-30ºC (59º-86ºF)

Active Ingredients

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate.

When Using This Product
  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lenses before using
Stop Use and Ask A Doctor If

you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours
If Pregnant Or Breast Feeding,

ask a health professional before use.

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

Quality Choice Eye Drops Irritation Relief 15ml


Structured Label Content

Use

  • for temporary relief of discomfort and redness of the eye due to minor eye irritation
Purposes

Redness reliever

Astringent

Warnings

For external use only

Directions

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

Other Information (Other information)

store at 15º-30ºC (59º-86ºF)

Active Ingredients (Active ingredients)

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate.

When Using This Product (When using this product)
  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lenses before using
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

Quality Choice Eye Drops Irritation Relief 15ml (Quality Choice Eye Drops Irritation Relief 15mL)


Advanced Ingredient Data


Raw Label Data

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