SPL v2
SPL
SPL Set ID 7d77bb0b-654d-904d-e053-2a91aa0a5543
Route
OPHTHALMIC
Published
Effective Date 2018-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyvinyl Alcohol (0.05 g) Povidone (0.06 g)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic, Dihydrate Edetate Disodium Hydrochloric Acid Sodium Phosphate, Monobasic, Dihydrate Potassium Chloride Water Sodium Bicarbonate Sodium Chloride Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-04-04

Description

Active ingredients                                  Purpose Polyvinyl alcohol 0.5%............................Lubricant Povidone 0.6%......................................Lubricant


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Directions

  • Instill 1 or 2 drops in the affected eye(s) as needed.
  • store at room temperature
  • remove contact lenses before using
Dosage and Administration

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree, City, GA 30269

www.valuelabels.com

1-866-696-0957

Made in Korea

Description

Active ingredients                                  Purpose Polyvinyl alcohol 0.5%............................Lubricant Povidone 0.6%......................................Lubricant

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • the condition worsens
  • symptoms last for more than 72 hours
Section 50567-7

When using this product

  • to avoid contamination, do not touch tip to any surface
  • replace cap after using

Section 50570-1

Do not use

  • if solution changes color or becomes cloudy.
Section 51727-6

Inactive ingredients

benzlkonium chloride, dibasic sodium phosphate hydrate, edetate disodium, glucose, hydrochloric acid, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate hydrate, sodium hydroxide

Section 51945-4

Section 55105-1

Uses

  • For the temporary relief of burning & irritation due to dryness of the eye
  • For use as a protectant against further irritation or to relieve dryness of the eye
Section 55106-9

Active ingredients                                  Purpose

Polyvinyl alcohol 0.5%............................Lubricant

Povidone 0.6%......................................Lubricant


Structured Label Content

Indications and Usage (34067-9)

Directions

  • Instill 1 or 2 drops in the affected eye(s) as needed.
  • store at room temperature
  • remove contact lenses before using
Dosage and Administration (34068-7)

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree, City, GA 30269

www.valuelabels.com

1-866-696-0957

Made in Korea

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 right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • the condition worsens
  • symptoms last for more than 72 hours
Section 50567-7 (50567-7)

When using this product

  • to avoid contamination, do not touch tip to any surface
  • replace cap after using

Section 50570-1 (50570-1)

Do not use

  • if solution changes color or becomes cloudy.
Section 51727-6 (51727-6)

Inactive ingredients

benzlkonium chloride, dibasic sodium phosphate hydrate, edetate disodium, glucose, hydrochloric acid, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate hydrate, sodium hydroxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

  • For the temporary relief of burning & irritation due to dryness of the eye
  • For use as a protectant against further irritation or to relieve dryness of the eye
Section 55106-9 (55106-9)

Active ingredients                                  Purpose

Polyvinyl alcohol 0.5%............................Lubricant

Povidone 0.6%......................................Lubricant


Advanced Ingredient Data


Raw Label Data

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