SPL v3
SPL
SPL Set ID 002da62b-aec6-8e2a-e063-6294a90a5efc
Route
OPHTHALMIC
Published
Effective Date 2023-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetrahydrozoline (0.05 g)
Inactive Ingredients
Water Sodium Chloride Benzalkonium Chloride Boric Acid Edetate Disodium Sodium Borate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-09
Description

Tetrahydrozoline HCl 0.05%

Purpose

Redness reliever

Medication Information

Purpose

Redness reliever

Description

Tetrahydrozoline HCl 0.05%

Use
  • relieves redness of the eye due to minor eye irritations
Section 51945-4

Warnings

For external use only

Directions

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

Active Ingredient

Tetrahydrozoline HCl 0.05%

Other Information

store at 15°-30°C ( 59°-86°F)

Inactive Ingredients

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

Questions Or Comments?

Call 833-358-6431

Monday to Friday

9:00am to 7:00pm EST

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

Structured Label Content

Use
  • relieves redness of the eye due to minor eye irritations
Section 51945-4 (51945-4)

Purpose

Redness reliever

Warnings

For external use only

Directions

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

Active Ingredient (Active ingredient)

Tetrahydrozoline HCl 0.05%

Other Information (Other information)

store at 15°-30°C ( 59°-86°F)

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 833-358-6431

Monday to Friday

9:00am to 7:00pm EST

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.917573 · Updated: 2026-03-14T23:12:02.945870