Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 43e690e4-b381-46e3-838c-33aef5bdadde
Route
OPHTHALMIC
Published
Effective Date 2021-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypromellose, Unspecified (2 mg) Tetrahydrozoline (0.5 mg) Zinc Cation (2.5 mg)
Inactive Ingredients
Menthol, Unspecified Form Polysorbate 80 Water Sodium Borate Boric Acid Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-21

Description

Hypromellose 0.2% Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%

Purpose

Hypromellose - Lubricant Tetrahydrozoline HCl - Redness reliever Zinc sulfate - Astringent


Medication Information

Purpose

Hypromellose - Lubricant

Tetrahydrozoline HCl - Redness reliever

Zinc sulfate - Astringent

Description

Hypromellose 0.2% Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%

Uses
  • temporarily relieves redness of the eye and discomfort due to
    • minor eyes irritations
    • exposure to wind or sun
  • temporarily relieves burning and irritation due to dryness of the eye
Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

Directions
  • put 1 or 2 drops in the affected eye(s) up to 4 times daily
  • tightly snap on cap to seal

Other information

  • store at 20-25°C (68-77°F)
Questions?

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Active Ingredients

Hypromellose 0.2%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Inactive Ingredients

boric acid, edetate disodium, menthol, polysorbate 80, purified water, sodium borate

When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
  • do not use if solution changes color or becomes cloudy
  • overuse may cause more eye redness
  • pupils may become enlarged temporarily
Stop Use and Ask A Doctor If
  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eyes lasts
  • condition worsens or lasts more than 72 hours
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Structured Label Content

Uses
  • temporarily relieves redness of the eye and discomfort due to
    • minor eyes irritations
    • exposure to wind or sun
  • temporarily relieves burning and irritation due to dryness of the eye
Purpose

Hypromellose - Lubricant

Tetrahydrozoline HCl - Redness reliever

Zinc sulfate - Astringent

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

Directions
  • put 1 or 2 drops in the affected eye(s) up to 4 times daily
  • tightly snap on cap to seal

Other information

  • store at 20-25°C (68-77°F)
Questions?

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Active Ingredients (Active ingredients)

Hypromellose 0.2%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Inactive Ingredients (Inactive ingredients)

boric acid, edetate disodium, menthol, polysorbate 80, purified water, sodium borate

When Using This Product (When using this product)
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
  • do not use if solution changes color or becomes cloudy
  • overuse may cause more eye redness
  • pupils may become enlarged temporarily
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 eyes lasts
  • condition worsens or lasts more than 72 hours
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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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