TEARS AGAIN- benzalkonium chloride, sodium phosphate, dibasic, edetate disodium,sodium phosphate, monobasic, sodium chloride, water, phosphoric acid, sodium hydroxide solution
OCuSOFT, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Active Ingredient	Purpose
Polyvinyl Alcohol 1.4%	Eye Lubricant

Uses

for the temporary relief of burning and irritation due to dryness of the eye.

Warnings

For use in the eyes only.

Do not use

if solution changes color, or becomes cloudy.

When using this product

avoid contamination, do not touch tip of container to any surface.
replace cap after using.
remove contact lenses before use.

Stop use and ask a doctor if

you experience eye pain, changes in vision, continued redness or irritation of the eye.
the condition worsens or persists for more than 72 hours.

Keep this and all drugs out of reach of children

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

Store at room temperature 15°-30°C (between 59°-86°F).
Keep tightly closed.
Do not use if imprinted seal on cap is torn, broken or missing.
Refer to carton for full product information.

Inactive Ingredients

Benzalkonium Chloride, Dibasic Sodium Phosphate, Edetate Disodium, Monobasic Sodium Phosphate, Sodium Chloride, and Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH.

Questions

Call (800) 223-5469 M-F 8:30AM - 5:00PM CST or visit www.ocusoft.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54799-904-15

Tears Again®
EYE DROPS
Sterile Lubricant

Polyvinyl Alcohol 1.4%

Gentle, Effective Relief for Dry, Irritated Eyes

OCuSOFT®

Net Wt 15 mL (0.5 fl oz)

For the Temporary Relief of Burning, Irritation and Discomfort Due to Dryness of the Eye

OCuSOFT®

Manufactured for OCuSOFT Inc.
Rosenberg, TX 77471 USA

© 2018 OCuSOFT Inc.
® marks owned by OCuSOFT Inc.

777-3-15
R0918

TEARS AGAIN
benzalkonium chloride, sodium phosphate, dibasic, edetate disodium,sodium phosphate, monobasic, sodium chloride, water, phosphoric acid, sodium hydroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54799-904
Route of Administration	INTRAOCULAR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) (Polyvinyl Alcohol, Unspecified - UNII:532B59J990)	Polyvinyl Alcohol, Unspecified	14 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Sodium Phosphate, Dibasic (UNII: GR686LBA74)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)
Sodium Chloride (UNII: 451W47IQ8X)
Water (UNII: 059QF0KO0R)
Phosphoric Acid (UNII: E4GA8884NN)
Sodium Hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54799-904-15	1 in 1 CARTON	08/01/2010	04/30/2023
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:54799-904-30	1 in 1 CARTON	08/01/2018	01/31/2023
2		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	08/01/2010	04/30/2023

Labeler - OCuSOFT, Inc. (174939207)

Revised: 10/2021

Document Id: a8479ee7-461e-4378-b2a4-57e977b3bc2a

Set id: eac4e03d-93c4-49ae-bcf7-32f1a6e59b4c

Version: 2

Effective Time: 20211025

OCuSOFT, Inc.