Careall Redness Reliever Eye Drops 0.5oz 550 (nbe Visine Original)

Careall Redness Reliever Eye Drops 0.5oz 550 (nbe Visine Original)
SPL v4
SPL
SPL Set ID 4f1bcc6a-9a1a-4617-99fe-016b264f0485
Route
OPHTHALMIC
Published
Effective Date 2025-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetrahydrozoline (0.5 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Edetate Disodium Water Sodium Chloride Sodium Borate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01

Description

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


Medication Information

Warnings and Precautions

Warnings

For external use only

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:

CareALL Products

160 Athens Way

Nashville, TN 37228

www.careallproducts.com

Made in South Korea

Description

Active ingredient Purpose Tetrahydrozoline HCl 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 eyes last
  • 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 the 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

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

Section 55106-9

Active ingredient Purpose

Tetrahydrozoline HCl 0.05%.................................. Eye redness reliever


Structured Label Content

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:

CareALL Products

160 Athens Way

Nashville, TN 37228

www.careallproducts.com

Made in South Korea

Warnings and Precautions (34071-1)

Warnings

For external use only

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 eyes last
  • 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 the 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)

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

Section 55106-9 (55106-9)

Active ingredient Purpose

Tetrahydrozoline HCl 0.05%.................................. Eye redness reliever


Advanced Ingredient Data


Raw Label Data

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