Label: SYSTANE DAY AND NIGHT VALUE PACK- polyethylene glycol 400, propylene glycol 0.3% kit
- NDC Code(s): 0065-1502-10
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
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- Official Label (Printer Friendly)
- SYSTANE® ULTRA Lubricant Eye Drops
- Uses
- Warnings
- Do not use
- When using this product
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions?
- SYSTANE® GEL DROPS Lubricant Eye Gel
- Uses
- Warnings
- Do not use
- When using this product
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions?
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DAY & NIGHT VALUE PACK
Systane®
ULTRA
LUBRICANT EYE DROPS
HIGH PERFORMING DRY EYE RELIEF
DAYTIME
Fast-acting hydration and lasting relief
Moisture-rich formula
#1 DOCTOR RECOMMENDED BRAND1
GEL DROPS
LUBRICANT EYE GEL
SOOTHING DRY EYE RELIEF
NIGHTTIME
Long-lasting formula
Day or night protection
LIQUID GEL
STERILE
Two 10 mL Bottles (1/3 FL OZ EACH)
Alcon®
This Value Pack
gives you fast-acting
hydration and
long-lasting relief,
for day or night
protection.
ACTUAL SIZE BOTTLES
TAMPER EVIDENT: For your
protection, each bottle has an
imprinted seal around the neck.
Do not use if seal is damaged or
missing at time of purchase.
www.alconpatents.com
ALCON LABORATORIES, INC.
Fort Worth, TX 76134 USA
Made in USA from domestic and
foreign materials
300048647-0621
LOT:
EXP.:Systane® ULTRA
LUBRICANT EYE DROPS
HIGH PERFORMANCE
STERILE
10 mL (1/3 FL OZ)
FOR EXTERNAL USE ONLY.
INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye.
DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed.
WARNINGS: See carton for WARNINGS.
INGREDIENTS:
Actives: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%.
Inactives: Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Store at room temperature.
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Alcon®
LOT:
EXP.:
300055616-1221
Systane®GEL DROPS
LUBRICANT EYE GEL
Soothing Dry Eye Relief
STERILE
10 mL (1/3 FL OZ)
FOR EXTERNAL USE ONLY.
Uses: See carton for USES.
WARNINGS: See carton for WARNINGS.
Directions: Shake well and put 1 or 2 drops in the affected eye(s) as needed.
INGREDIENTS:
Actives: Polyethylene Glycol 0.4% and Propylene Glycol 0.3%.
Inactives: Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Store at room temperature.
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Alcon
LOT:
EXP.:
300048641-0621 -
INGREDIENTS AND APPEARANCE
SYSTANE DAY AND NIGHT VALUE PACK
polyethylene glycol 400, propylene glycol 0.3% kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-1502 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-1502-10 1 in 1 CARTON; Type 0: Not a Combination Product 10/24/2017 04/30/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 10 mL Part 2 1 BOTTLE 10 mL Part 1 of 2 SYSTANE ULTRA LUBRICANT EYE DROPS
polyethylene glycol 400, propylene glycol solutionProduct Information Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 400 4 mg in 1 mL Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength Aminomethylpropanol (UNII: LU49E6626Q) Boric Acid (UNII: R57ZHV85D4) Guar Gum (UNII: E89I1637KE) Polidronium Chloride (UNII: 6716Z5YR3G) Potassium Chloride (UNII: 660YQ98I10) Water (UNII: 059QF0KO0R) Sodium Chloride (UNII: 451W47IQ8X) Hydrochloric Acid (UNII: QTT17582CB) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 10/24/2017 Part 2 of 2 SYSTANE DROPS
polyethylene glycol 400, propylene glycol solutionProduct Information Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 400 4 mg in 1 mL Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength Aminomethylpropanol (UNII: LU49E6626Q) Boric Acid (UNII: R57ZHV85D4) Edetate Disodium (UNII: 7FLD91C86K) Guar Gum (UNII: E89I1637KE) Polidronium Chloride (UNII: 6716Z5YR3G) Potassium Chloride (UNII: 660YQ98I10) Sodium Chloride (UNII: 451W47IQ8X) Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) Hydrochloric Acid (UNII: QTT17582CB) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 10/24/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 10/24/2017 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Alcon Research LLC 007672236 manufacture(0065-1502)