NDC | 0065-1431-01, 0065-1431-05, 0065-1431-18, 0065-1431-21, 0065-1431-28, 0065-1431-31, 0065-1431-41, 0065-1431-80 |
Set ID | 0537c23a-15f7-be64-1231-a6c93468e9a8 |
Category | HUMAN OTC DRUG LABEL |
Packager | Alcon Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART349 |
- ACTIVE INGREDIENT
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions?
- Drug Facts
- ACTIVE INGREDIENT
- Uses
- Warnings
- Do Not Use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Questions?
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- Do not use
- When using this product
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions?
-
PRINCIPAL DISPLAY PANEL
Systane*
ULTRA
LUBRICANT EYE DROPS
HIGH PERFORMANCE
EXTENDED PROTECTION
FAST SYMPTOM RELIEF
#1 Doctor
Recommended
Dry Eye Brand†
Alcon®
STERILE
3 mL (0.1 FL OZ)Systane® ULTRA
LUBRICANT EYE DROPS
HIGH PERFORMANCE
EXTENDED PROTECTION
FAST SYMPTOM RELIEF
#1 Doctor Recommended Brand1
Alcon
STERILE
3mL (0.1 FL OZ)Systane® ULTRA
LUBRICANT EYE DROPS
HIGH PERFORMANCE
EXTENDED PROTECTION
FAST SYMPTOM RELIEF
#1 Doctor Recommended Brand1
Alcon
STERILE
10 mL (⅓ FL OZ)Systane®
LUBRICANT EYE DROPS
ULTRA
HIGH PERFORMING DRY EYE RELIEF
Fast-acting hydration and lasting relief
Moisture rich formula
#1 Doctor Recommended Brand1
Alcon
STERILE
10 mL (1/3 FL OZ) -
INGREDIENTS AND APPEARANCE
SYSTANE ULTRA
polyethylene glycol 400 and propylene glycol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-1431 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) Sorbitol (UNII: 506T60A25R) Hydrochloric Acid (UNII: QTT17582CB) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-1431-80 1 in 1 CARTON 10/01/2014 1 3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:0065-1431-01 1 in 1 CARTON 10/01/2014 2 1.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:0065-1431-05 1 in 1 CARTON 10/01/2014 3 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 4 NDC:0065-1431-18 3 in 1 CARTON 10/01/2014 4 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 5 NDC:0065-1431-21 1 in 1 CARTON 10/01/2014 5 3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 6 NDC:0065-1431-28 2 in 1 CARTON 10/01/2014 6 4 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 7 NDC:0065-1431-31 1 in 1 CARTON 10/01/2014 7 4 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 8 NDC:0065-1431-41 2 in 1 CARTON 10/01/2014 8 10 mL in 1 BOTTLE, DROPPER; 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 10/01/2014 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Alcon Research LLC 007672236 manufacture(0065-1431) Establishment Name Address ID/FEI Business Operations Alcon Singapore Manufacturing Pte Ltd 595170137 manufacture(0065-1431)