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NDC 54799-0904-30 Tears Again 14 mg/mL Details

Tears Again 14 mg/mL

Tears Again is a INTRAOCULAR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by OCuSOFT, Inc.. The primary component is POLYVINYL ALCOHOL, UNSPECIFIED.

Product Information

NDC	54799-0904
Product ID	54799-904_a8479ee7-461e-4378-b2a4-57e977b3bc2a
Associated GPIs	86200050002030
GCN Sequence Number	007936
GCN Sequence Number Description	polyvinyl alcohol DROPS 1.4 % OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	33422
HICL Sequence Number	005225
HICL Sequence Number Description	POLYVINYL ALCOHOL
Brand/Generic	Generic
Proprietary Name	Tears Again
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride, Sodium Phosphate, Dibasic, Edetate Disodium,Sodium Phosphate, Monobasic, Sodium Chloride, Water, Phosphoric Acid, Sodium Hydroxide
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	INTRAOCULAR
Active Ingredient Strength	14
Active Ingredient Units	mg/mL
Substance Name	POLYVINYL ALCOHOL, UNSPECIFIED
Labeler Name	OCuSOFT, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	n/a

Package

Package Images

NDC 54799-0904-30 (54799090430)

Pricing Information	N/A
NDC Package Code	54799-904-30
Billing NDC	54799090430
Package	1 BOTTLE, DROPPER in 1 CARTON (54799-904-30) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2018-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eac4e03d-93c4-49ae-bcf7-32f1a6e59b4c Details

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

INGREDIENTS AND APPEARANCE

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