Artificial Tears Ophthalmic Solution

Artificial Tears Ophthalmic Solution
SPL v4
SPL
SPL Set ID f18bebf2-1936-658f-e053-2a95a90a5012
Route
OPHTHALMIC
Published
Effective Date 2022-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextran 70 (1 mg) Glycerin (2 mg) Hypromelloses (3 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Glycine Magnesium Chloride Polysorbate 80 Potassium Chloride Water Sodium Chloride Zinc Chloride Benzalkonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-05

Description

Active ingredients Purpose Dextran 70 0.1% Lubricant Glycerin 0.2% Lubricant Hypromellose 0.3% Lubricant


Medication Information

Description

Active ingredients Purpose Dextran 70 0.1% Lubricant Glycerin 0.2% Lubricant Hypromellose 0.3% Lubricant

Uses
  • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun
  • May be used as a protectant against further irritation
Section 50566-9

Stop use and ask a doctor if you experience any of the following:

  • You experience eye pain, changes in vision, continued redness and irritation of the eye
  • The condition worsens or persists for more than 72 hours
Section 55105-1
Active ingredients Purpose
Dextran 70 0.1% Lubricant
Glycerin 0.2% Lubricant
Hypromellose 0.3% Lubricant
Warnings

For use in the eyes only

Directions
  • Shake well before use
  • Instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use
  • if this solution changes color or becomes cloudy
Questions?

1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

Other Information
  • store at room temperature
Inactive Ingredients:

benzalkonium chloride, boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

Principal Display Panel

When Using This Product
  • Avoid contamination, do not touch tip of container to any surface
  • Replace cap after use
Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun
  • May be used as a protectant against further irritation
Section 50566-9 (50566-9)

Stop use and ask a doctor if you experience any of the following:

  • You experience eye pain, changes in vision, continued redness and irritation of the eye
  • The condition worsens or persists for more than 72 hours
Section 55105-1 (55105-1)
Active ingredients Purpose
Dextran 70 0.1% Lubricant
Glycerin 0.2% Lubricant
Hypromellose 0.3% Lubricant
Warnings

For use in the eyes only

Directions
  • Shake well before use
  • Instill 1 or 2 drops in the affected eye(s) as needed
Do Not Use (Do not use)
  • if this solution changes color or becomes cloudy
Questions?

1-855-361-3993

Distributed by:

AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

Other Information
  • store at room temperature
Inactive Ingredients: (Inactive ingredients:)

benzalkonium chloride, boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • Avoid contamination, do not touch tip of container to any surface
  • Replace cap after use
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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