Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2d80ae24-1f9b-43d2-e054-00144ff88e88
Route
OPHTHALMIC
Published
Effective Date 2011-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetrahydrozoline (0.5 mg) Dextran 70 (1 mg) Polyethylene Glycol 400 (10 mg) Povidone
Inactive Ingredients
Boric Acid Sodium Borate Edetate Disodium Benzalkonium Chloride Sodium Chloride Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-11

Description

Dextran 70 0.1% Polyethylene Glycol 400 1% Povidone 1% Tetrahydrozoline HCl 0.5%

Purpose

Lubricant Lubricant Lubricant Redness reliever


Medication Information

Purpose

Lubricant

Lubricant

Lubricant

Redness reliever

Description

Dextran 70 0.1% Polyethylene Glycol 400 1% Povidone 1% Tetrahydrozoline HCl 0.5%

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

Warnings

Ask a doctor before use if you have narrow angle glaucoma

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

Package Label

Optimis7

Active Ingredient

Dextran 70 0.1%

Polyethylene Glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.5%

Other Information
  • store between 15° to 25°C (59°F to 77°F)



Inactive Ingredients

boric acid, sodium borate, edetate disodium, benzalkonium chloride, sodium chloride, dilite hydrochloric acid, sterile purified water

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 become 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

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 right away.


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

Purpose

Lubricant

Lubricant

Lubricant

Redness reliever

Warnings

Ask a doctor before use if you have narrow angle glaucoma

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

Package Label (package label)

Optimis7

Active Ingredient

Dextran 70 0.1%

Polyethylene Glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.5%

Other Information (Other information)
  • store between 15° to 25°C (59°F to 77°F)



Inactive Ingredients (Inactive ingredients)

boric acid, sodium borate, edetate disodium, benzalkonium chloride, sodium chloride, dilite hydrochloric acid, sterile purified water

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 become 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

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 right away.


Advanced Ingredient Data


Raw Label Data

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