drug facts

drug facts
SPL v15
SPL
SPL Set ID 209bcec8-fbb4-4079-8ae2-810c48f3de93
Route
ophthalmic
Published
Effective Date 2018-11-19
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
boric acid edetate disodium menthol, unspecified form polysorbate 80 water sodium borate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2005-09-27

Purpose

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

Description

Hypromellose 0.2% Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%


Medication Information

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

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

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)
Inactive Ingredients

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

Description

Hypromellose 0.2% Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%

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%

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
  • remove contact lenses before using
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

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

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

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)
Inactive Ingredients (Inactive ingredients)

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

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%

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
  • remove contact lenses before using
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)

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