Artifical Tears
- Manufacturer
- medsource pharmaceuticals
- Effective date
- 2018-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:57:53
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients Purpose
Polyvinyl alcohol 0.5%............................Lubricant
Povidone 0.6%......................................Lubricant
OTC - PURPOSE SECTION
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
WARNINGS SECTION
Warnings
For external use only.
OTC - DO NOT USE SECTION
Do not use
- if solution changes color or becomes cloudy.
OTC - WHEN USING SECTION
When using this product
- to avoid contamination, do not touch tip to any surface
- replace cap after using
OTC - STOP USE SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
Directions
- Instill 1 or 2 drops in the affected eye(s) as needed.
- store at room temperature
- remove contact lenses before using
INACTIVE INGREDIENT SECTION
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
DOSAGE & ADMINISTRATION SECTION
Distributed by:
Geiss, Destin & Dunn, Inc.
Peachtree, City, GA 30269
1-866-696-0957
Made in Korea
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45865-744-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-75e9-d83d-e063-dadaa90ab31f | 7d77bb0b-654d-904d-e053-2a91aa0a5543 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45865-744-01 | Artifical Tears | 1 in 1 PACKAGE | SOLUTION/ DROPS | 1 | 2 | |
| 45865-744-01 | Artifical Tears | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50804-017-05 | ML - Milliliter | 50804-017 | a3e6d87d-d28f-48bb-96c0-24273bc46e1b | 1 | 2018-04-19 |
Products#
Every source-derived product name is available through these pages.
- Artifical Tears
- Polyvinyl alcohol, and Povidone
- BENZALKONIUM CHLORIDE
- SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
- EDETATE DISODIUM
- HYDROCHLORIC ACID
- SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
- POTASSIUM CHLORIDE
- WATER
- SODIUM BICARBONATE
- SODIUM CHLORIDE
- SODIUM HYDROXIDE
- POLYVINYL ALCOHOL
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45865-744 | 45865-744-01 |
| 50804-017 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7d77bb22-3b4b-867d-e053-2a91aa0aee65 | 7d77bb0b-654d-904d-e053-2a91aa0a5543 | 2018-12-20 | Warnings | 7d77bb22-3b4b-867d-e053-2a91aa0aee65 7d77bb0b-654d-904d-e053-2a91aa0a5543 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
