Goodsense Eye Drops Advanced Relief Moisturizer (pld)

Goodsense Eye Drops Advanced Relief Moisturizer (pld)
SPL v3
SPL
SPL Set ID 9b34de99-13df-201a-e053-2a95a90ae559
Route
OPHTHALMIC
Published
Effective Date 2020-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (1 g) Tetrahydrozoline (0.05 g) Povidone (0.1 g) Dextran 70
Inactive Ingredients
Benzalkonium Chloride Boric Acid Sodium Borate Edetic Acid Water Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-02

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

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 (1-800-111-1222) 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 changed 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 55106-9

Active Ingredients

Dextran 70.....0.1%

Polyethylene glycol 400.....1%

Povidone.....1%

tetrahydrozoline HCl.....0.05%


Structured Label Content

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.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison control Center (1-800-111-1222) 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 changed 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 55106-9 (55106-9)

Active Ingredients

Dextran 70.....0.1%

Polyethylene glycol 400.....1%

Povidone.....1%

tetrahydrozoline HCl.....0.05%


Advanced Ingredient Data


Raw Label Data

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