OTC Medication Information: Artificial Tears

ARTIFICIAL TEARS- dextran 70, glycerin and hypromelloses solution/ drops
AvPAK

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

Warnings

For use in the eyes only

Do not use

  • if this solution changes color or becomes cloudy

When using this product

  • Avoid contamination, do not touch tip of container to any surface
  • Replace cap after use

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

Keep out of reach of children.

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

Directions

  • Shake well before use
  • Instill 1 or 2 drops in the affected eye(s) as needed

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.

Questions?

1-855-361-3993

Distributed by:
AvKARE

Pulaski, TN 38478

www.avkare.com

Rev. 12/2022 AV 12/2022

PRINCIPAL DISPLAY PANEL

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ARTIFICIAL TEARS
artificial tears solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50268-043
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTRAN 70 (DEXTRAN 70) DEXTRAN 70 1 mg in 1 mL
GLYCERIN (GLYCERIN) GLYCERIN 2 mg in 1 mL
HYPROMELLOSES (HYPROMELLOSES) HYPROMELLOSES 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID
CALCIUM CHLORIDE
GLYCINE
MAGNESIUM CHLORIDE
POLYSORBATE 80
POTASSIUM CHLORIDE
WATER
SODIUM CHLORIDE
ZINC CHLORIDE
BENZALKONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-043-15 15 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M018 01/05/2023
Labeler — AvPAK (832926666)

Revised: 03/2024 AvPAK

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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