NDC | 0065-1502-10 |
Set ID | df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07 |
Category | HUMAN OTC DRUG LABEL |
Packager | Alcon Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART349 |
- 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
© 2018 Novartis
ALCON LABORATORIES, INC.
Fort Worth, TX 76134 USA
Made in USA from domestic and foreign materials
9015877-0218
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.:
H14351-0516Systane®GEL DROPS
LUBRICANT EYE DROPS
ANYTIME PROTECTION
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 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.
6201 South Freeway,
Fort Worth, TX 76134 USA
©2010, 2013 Novartis
Alcon®
LOT:
EXP.:
H14343-0416 -
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 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 final part349 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 final part349 10/24/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 10/24/2017 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Alcon Research LLC 007672236 manufacture(0065-1502)