qc eye drops, original 0.5oz (nbe visine original) 90377

qc eye drops, original 0.5oz (nbe visine original) 90377
SPL v4
SPL
SPL Set ID 24c27fd0-42c5-5378-e063-6394a90a5fe8
Route
ophthalmic
Published
Effective Date 2024-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tetrahydrozoline (0.5 mg)
Inactive Ingredients
sodium borate edetate disodium benzalkonium chloride water sodium chloride boric acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-08-01

Description

Active ingredient Purpose Tetrahydrozoline HCI 0.05%...........................................Eye redness reliever


Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredient Purpose

Tetrahydrozoline HCI 0.05%...........................................Eye redness reliever

Indications and Usage

Directions

  • to open bottle, push cap down and twist counterclockwise
  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor
Dosage and Administration

Distributed by:

CDMA, Inc.

Novi, MI 48375

Made in South Korea

Description

Active ingredient Purpose Tetrahydrozoline HCI 0.05%...........................................Eye redness reliever

Section 44425-7

Other information

recommended storage between 15-25°C (59-77°F)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

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
Section 50567-7

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
Section 50569-3

Ask a doctor before use if you have narrow angle glaucoma

Section 51727-6

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Section 51945-4

Section 53414-9

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

Section 55105-1

Use

for the relief of redness of the eye due to minor eye irritations


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredient Purpose

Tetrahydrozoline HCI 0.05%...........................................Eye redness reliever

Indications and Usage (34067-9)

Directions

  • to open bottle, push cap down and twist counterclockwise
  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor
Dosage and Administration (34068-7)

Distributed by:

CDMA, Inc.

Novi, MI 48375

Made in South Korea

Section 44425-7 (44425-7)

Other information

recommended storage between 15-25°C (59-77°F)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50569-3 (50569-3)

Ask a doctor before use if you have narrow angle glaucoma

Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Use

for the relief of redness of the eye due to minor eye irritations


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)