SPL v7
SPL
SPL Set ID 8aad89f9-d29c-4668-b58d-8dc0d266bc01
Route
OPHTHALMIC
Published
Effective Date 2024-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetrahydrozoline (.5 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Edetate Disodium Water Sodium Chloride Sodium Borate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-06-01 Until 2026-10-01
Description

Tetrahydrozoline HCl 0.05%

Medication Information

Warnings and Precautions

Ask a doctor before use if you have narrow angle glaucoma

When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch the tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eyes last
  • condition worsens or lasts more than 72 hours

If pregnant or breast feeding, ask a health professional before use.

Dosage and Administration

Put 1 to 2 drops in the effected eye(s) up to 4 times daily. 

Children under 6 years of age: ask a doctor

Description

Tetrahydrozoline HCl 0.05%

Use

For the relief of redness of the eye due to minor eye irritations

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

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

Section 51945-4

Section 53413-1

Distributed by: NWI, Inc.  160 Athens Way.  Nashville, TN 37228

(615)329-1906

Section 55105-1

Redness Reliever

Section 55106-9

Tetrahydrozoline HCl 0.05%

Structured Label Content

Use

For the relief of redness of the eye due to minor eye irritations

Dosage and Administration (34068-7)

Put 1 to 2 drops in the effected eye(s) up to 4 times daily. 

Children under 6 years of age: ask a doctor

Warnings and Precautions (34071-1)

Ask a doctor before use if you have narrow angle glaucoma

When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch the tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eyes last
  • condition worsens or lasts more than 72 hours

If pregnant or breast feeding, ask a health professional before use.

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Distributed by: NWI, Inc.  160 Athens Way.  Nashville, TN 37228

(615)329-1906

Section 55105-1 (55105-1)

Redness Reliever

Section 55106-9 (55106-9)

Tetrahydrozoline HCl 0.05%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:41.559821 · Updated: 2026-03-14T23:03:53.608631