medic's choice eye drops advanced

medic's choice eye drops advanced
SPL v5
SPL
SPL Set ID ab906fd8-265c-4359-a920-d626366e245c
Route
ophthalmic
Published
Effective Date 2019-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
povidone (10 mg) polyethylene glycol 400 (0.5 mg) tetrahydrozoline (1 mg) dextran 70
Inactive Ingredients
benzalkonium chloride edetic acid water sodium borate sodium chloride boric acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2003-12-09

Description

Active ingredients Dextran 70 0.1% Polyethylene glycol 400 1% Povidone 1% Tetrahydrozoline HCl 0.05%


Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Indications and Usage

Uses

  • relieves redness of the eye due to minor eye irritations
  • as a lubricant to prevent further irritation or to relieve dryness of the eye
Dosage and Administration

Directions

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Description

Active ingredients Dextran 70 0.1% Polyethylene glycol 400 1% Povidone 1% Tetrahydrozoline HCl 0.05%

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 experience

■ eye pain

■ changes in vision

■ continued redness or irritation of the eye, or if the condition worsens or persists for

more than 72 hours

Section 50567-7

When using this product

■ pupils may become enlarged temporarily

■ to avoid contamination, do not touch tip of container to any surface.

Replace cap after using.

■ if solution changes color or becomes cloudy, do not use

■ overuse may produce increased redness of the eye

■ remove contact lens before using

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, and

sodium chloride

Section 51945-4

Section 53414-9

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

Section 55105-1

Purposes

Dextran 70..................Lubricant

Polyethylene glycol 400....Lubricant

Povidone...........................Lubricant

Tetrahydrozoline HCl........Redness reliever

Section 60561-8

Other information

store at 15°-30°C (59°-86°F)


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Indications and Usage (34067-9)

Uses

  • relieves redness of the eye due to minor eye irritations
  • as a lubricant to prevent further irritation or to relieve dryness of the eye
Dosage and Administration (34068-7)

Directions

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

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 experience

■ eye pain

■ changes in vision

■ continued redness or irritation of the eye, or if the condition worsens or persists for

more than 72 hours

Section 50567-7 (50567-7)

When using this product

■ pupils may become enlarged temporarily

■ to avoid contamination, do not touch tip of container to any surface.

Replace cap after using.

■ if solution changes color or becomes cloudy, do not use

■ overuse may produce increased redness of the eye

■ remove contact lens before using

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, and

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)

Purposes

Dextran 70..................Lubricant

Polyethylene glycol 400....Lubricant

Povidone...........................Lubricant

Tetrahydrozoline HCl........Redness reliever

Section 60561-8 (60561-8)

Other information

store at 15°-30°C (59°-86°F)


Advanced Ingredient Data


Raw Label Data

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