NDC 0065-1507 Systane Ultra Preservative Free
Polyethylene Glycol 400 And Propylene Glycol Solution/ Drops Ophthalmic
Product Information
What is NDC 0065-1507?
The NDC code 0065-1507 is assigned by the FDA to the product Systane Ultra Preservative Free which is a human over the counter drug product labeled by Alcon Laboratories, Inc.. The generic name of Systane Ultra Preservative Free is polyethylene glycol 400 and propylene glycol. The product's dosage form is solution/ drops and is administered via ophthalmic form. The product is distributed in a single package with assigned NDC code 0065-1507-82 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Systane Ultra Preservative Free?
For the temporary relief of burning and irritation due to dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
Product Packages
NDC Code 0065-1507-82
Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Details
What are Systane Ultra Preservative Free Active Ingredients?
- POLYETHYLENE GLYCOL 400 4 mg/mL
- PROPYLENE GLYCOL 3 mg/mL - A clear, colorless, viscous organic solvent and diluent used in pharmaceutical preparations.
Systane Ultra Preservative Free Active Ingredients UNII Codes
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (Active Moiety)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 477589 - polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic Solution
- RxCUI: 477589 - polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic Solution
- RxCUI: 477589 - PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic Solution
Systane Ultra Preservative Free Inactive Ingredients UNII Codes
- AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
- BORIC ACID (UNII: R57ZHV85D4)
- GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC)
- POTASSIUM CHLORIDE (UNII: 660YQ98I10)
- WATER (UNII: 059QF0KO0R)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- SORBITOL (UNII: 506T60A25R)
- HYDROCHLORIC ACID (UNII: QTT17582CB)
- SODIUM HYDROXIDE (UNII: 55X04QC32I)
* Please review the disclaimer below.
Systane Ultra Preservative Free Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
Uses
- for the temporary relief of burning and irritation due to dryness of the eye
- for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
Warnings
For external use only
Do Not Use
- if this product changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
When Using The Product
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- shake well before using
- put 1 or 2 drops in the affected eye(s) as needed
- see side of carton for directions for use
Other Information
- Store at room temperature
Inactive Ingredients
Aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Questions?
In the U.S. call 1-800-757-9195
[email protected]
www.systane.com
Directions For Use:
- Hold the bottle just below the cap and twist the cap to open.
- BEFORE FIRST USE, hold the bottle upside down and dispense one drop of product to discard.
- Shake the bottle downward to remove residual product (see picture).
- Place 1 or 2 drops in the affected eye(s) as needed and blink.
- After use, shake the bottle downward to remove residual product that may be left on the tip (see picture above).
- Replace cap after use.
Principal Display Panel
Systane®
LUBRICANT EYE DROPS
ULTRA PF
PRESERVATIVE-FREE
DRY EYE RELIEF
Fast-acting hydration and lasting relief
Moisture rich formula for sensitive eyes
DOCTOR RECOMMENDED #1 Brand1
STERILE
10 mL (0.34 FL OZ)
Alcon
SIDE PANEL:
TAMPER EVIDENT:
For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.
1Based on a survey of eye care professionals. Data on file.
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin United States
www.alconpatents.com
300049462-0721
* Please review the disclaimer below.