Colirio Ocusan ®

Colirio Ocusan ®
SPL v5
SPL
SPL Set ID 0f0dd0bd-9a35-4671-933a-f3f8e834ae65
Route
OPHTHALMIC
Published
Effective Date 2019-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetrahydrozoline (0.5 mg) Polyethylene Glycol, Unspecified (10 mg) Povidone, Unspecified (1 mg) Dextran 70
Inactive Ingredients
Boric Acid Sodium Borate Edetate Disodium Benzalkonium Chloride Sodium Chloride Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-16

Description

Drug Facts


Medication Information

Description

Drug Facts

Use
  • for the relief of redness of the eye due to minor eye irritations
  • for use as a protectant against further irritation or to relieve dryness of the eye
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 breastfeeding,ask a health professional before use.

Section 55105-1
Active ingredients Purposes
Dextran 70 0.1% Lubricant
Polyethylene Glycol 400 1% Lubricant
Povidone 1% Lubricant
Tetrahydrozoline HCl 0.05% Redness reliever
Warnings

For external use only

Questions

1-800-858-3889

Directions
  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor
Other Information
  • store at 15° to 25°C (59° to 77°F)
Inactive Ingredients

benzalkonium chloride, boric acid, disodium edetate hydrate, sodium borate, sodium chloride, water for injection

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
Principal Display Panel 15 Ml Bottle Box

Improved Formula!

Now

with

3

Moisturizers

Maximum

Strength

Colirio

Ocusan ®

Fast Redness Relief

Soothes & Lubricates

Redness Reliever /

Lubricant Eye Drops

STERILE

1/2 FL OZ (15 mL)


Structured Label Content

Use
  • for the relief of redness of the eye due to minor eye irritations
  • for use as a protectant against further irritation or to relieve dryness of the eye
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 breastfeeding,ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients Purposes
Dextran 70 0.1% Lubricant
Polyethylene Glycol 400 1% Lubricant
Povidone 1% Lubricant
Tetrahydrozoline HCl 0.05% Redness reliever
Warnings

For external use only

Questions

1-800-858-3889

Directions
  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor
Other Information (Other information)
  • store at 15° to 25°C (59° to 77°F)
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, boric acid, disodium edetate hydrate, sodium borate, sodium chloride, water for injection

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
Principal Display Panel 15 Ml Bottle Box (PRINCIPAL DISPLAY PANEL - 15 mL Bottle Box)

Improved Formula!

Now

with

3

Moisturizers

Maximum

Strength

Colirio

Ocusan ®

Fast Redness Relief

Soothes & Lubricates

Redness Reliever /

Lubricant Eye Drops

STERILE

1/2 FL OZ (15 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)