visine ®

visine ®
SPL v1
SPL
SPL Set ID dcd4164c-aa1e-4f07-ab2c-b439275629db
Route
ophthalmic
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tetrahydrozoline (0.5 mg) polyethylene glycol 400 (10 mg)
Inactive Ingredients
boric acid ascorbic acid dextrose, unspecified form glycerin glycine hypromellose, unspecified magnesium chloride polixetonium chloride potassium chloride water sodium citrate, unspecified form sodium lactate sodium phosphate, dibasic, anhydrous

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-04-27
Description

Drug Facts

Medication Information

Warnings

For external use only.

Uses
  • for the relief of redness of the eye due to minor eye irritations
  • for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye
Directions
  • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day
  • children under 6 years of age: consult a doctor
  • children under 2 years of age: do not use
Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic

Description

Drug Facts

Principal Display Panel

Questions?

call toll-free 888-734-7648or 215-273-8755(collect)

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50569-3

Ask a doctor before use if you havenarrow angle glaucoma.

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
Polyethylene glycol 400 1% Lubricant
Tetrahydrozoline HCl 0.05% Redness reliever
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 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 eye lasts
  • condition worsens or lasts more than 72 hours

Structured Label Content

Warnings

For external use only.

Uses
  • for the relief of redness of the eye due to minor eye irritations
  • for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye
Directions
  • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day
  • children under 6 years of age: consult a doctor
  • children under 2 years of age: do not use
Other Information (Other information)

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Questions?

call toll-free 888-734-7648or 215-273-8755(collect)

Section 42229-5 (42229-5)

Drug Facts

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 50569-3 (50569-3)

Ask a doctor before use if you havenarrow angle glaucoma.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Polyethylene glycol 400 1% Lubricant
Tetrahydrozoline HCl 0.05% Redness reliever
When Using This Product (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 tip of container to any surface to avoid contamination
  • replace cap after each use
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:20.892235 · Updated: 2026-03-14T23:09:03.764166