NDC 0065-1433
Systane Balance
Propylene Glycol
Systane Balance is a Ophthalmic Emulsion in the Human Otc Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Propylene Glycol.
| Product ID | 0065-1433_10ae443e-f6fd-4501-9b03-bf7a21eed119 |
| NDC | 0065-1433 |
| Product Type | Human Otc Drug |
| Proprietary Name | Systane Balance |
| Generic Name | Propylene Glycol |
| Dosage Form | Emulsion |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2010-07-27 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part349 |
| Labeler Name | Alcon Laboratories, Inc. |
| Substance Name | PROPYLENE GLYCOL |
| Active Ingredient Strength | 0 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 0065-1433-02
1 BOTTLE, DROPPER in 1 CARTON (0065-1433-02) > 10 mL in 1 BOTTLE, DROPPER
| Marketing Start Date | 2010-07-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0065-1433-45 [00065143345]
Systane Balance EMULSION
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2015-06-18 |
| Marketing End Date | 2017-12-15 |
NDC 0065-1433-11 [00065143311]
Systane Balance EMULSION
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2010-07-27 |
NDC 0065-1433-43 [00065143343]
Systane Balance EMULSION
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2015-06-18 |
| Marketing End Date | 2017-12-15 |
NDC 0065-1433-07 [00065143307]
Systane Balance EMULSION
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-07-27 |
NDC 0065-1433-46 [00065143346]
Systane Balance EMULSION
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2015-06-18 |
| Marketing End Date | 2017-12-15 |
NDC 0065-1433-02 [00065143302]
Systane Balance EMULSION
| Marketing Category | OTC monograph final |
| Application Number | part349 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-07-27 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PROPYLENE GLYCOL | .06 mg/mL |
OpenFDA Data
| SPL SET ID: | c7b1a03a-a5f2-409e-a34a-d6f166671de5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Systane Balance" or generic name "Propylene Glycol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0065-1433 | Systane Balance | propylene glycol |
| 82736-016 | Anti Hair Loss Gel with Arnica, Rosemary, and Lemon Extracts. | PROPYLENE GLYCOL |
| 79539-401 | Baby Wipes | Propylene Glycol |
| 76168-714 | CVS Health Lubricant Drops | propylene glycol |
| 69842-446 | CVS Lubricant Eye Drops 15mL | Propylene glycol |
| 49035-243 | Equate Lubricant Eye Drops Restorative Performance | Propylene glycol |
| 49035-145 | Equate Support Moisture Lubricant Eye | Propylene Glycol |
| 82736-019 | Eyelash and Eyebrow Lengthener | PROPYLENE GLYCOL |
| 37808-650 | HEB Lubricant Eye Drops Dry Eye Therapy | Propylene glycol |
| 11673-155 | Lubricant Eye Drops Restorative Performance | propylene glycol |
| 11822-3728 | Lubricant Eye Drops Restorative Performance | propylene glycol |
| 76369-3001 | MSM (MoSaengMo) | PROPYLENE GLYCOL |
| 76369-5001 | MSM (MoSaengMo) | PROPYLENE GLYCOL |
| 76369-6001 | MSM (MoSaengMo) | PROPYLENE GLYCOL |
| 70000-0013 | Restorative Formula Lubricant Eye Drops | propylene glycol |
| 11822-4811 | RITE AID Lubricant Drops | propylene glycol |
| 70000-0587 | Sterile Lubricant drops | propylene glycol |
| 0065-0481 | Systane COMPLETE | propylene glycol |
| 0065-1509 | Systane COMPLETE PF | propylene glycol |
| 0065-1530 | Systane COMPLETE PF | propylene glycol |
| 57619-302 | Thrive Eye Drops Nanodrop | Propylene Glycol |
| 77790-003 | VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 ml | Propylene glycol |
| 0363-7864 | Walgreen Sterile Lubricant | Propylene Glycol |
| 0363-1474 | Walgreens Lubricant Eye Drops Restorative Performance | Propylene Glycol |
Trademark Results [Systane Balance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYSTANE BALANCE 87673557 5438390 Live/Registered |
Novartis AG 2017-11-06 |
 SYSTANE BALANCE 85009356 3943251 Dead/Cancelled |
NOVARTIS AG 2010-04-08 |
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