Label: SYSTANE COMPLETE- propylene glycol solution/ drops
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NDC Code(s):
0065-0481-01,
0065-0481-10,
0065-0481-11,
0065-0481-55, view more0065-0481-72
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 24, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
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
- for use as a protectant against further irritation or to relieve dryness of the eye
- for use as a lubricant to prevent further irritation or to relieve dryness of the eye
-
Warnings
For external use only
When using this product
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
- Directions
- Other Information
- Inactive Ingredients
- Questions?
-
PRINCIPAL DISPLAY PANEL
Systane®
LUBRICANT EYE DROPS
COMPLETE
OPTIMAL DRY EYE RELIEF
Fast-acting hydration
Tear evaporation protection
Nano-droplets for better coverage*
#1 DOCTOR RECOMMENDED BRAND1
nano droplet
Alcon
STERILE
10mL (1/3 FL OZ)
LOT: EXP.:SIDE PANEL
TAMPER EVIDENT: For your protection,
this bottle has an imprinted seal around
the neck. Do not use if seal is damaged or
missing at time of purchase.
SYSTANE®
COMPLETE
Our most advanced
formula ever!
SYSTANE®
COMPLETE
Lubricant
Eye Drops
hydrates
fast, protects
against tear
evaporation, and
helps support all layers
of the tear film.
Nano droplet technology:*
● a better delivery of the
active ingredient
● better eye coverage
ACTUAL SIZE
Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76143 USA
* vs SYSTANE® BALANCE
1Based on a survey of eye care professionals.
Data on file.
www.alconpatents.com
Made in USA from domestic and imported materials
300048645-0621
Systane®
LUBRICANT EYE DROPS
COMPLETE
OPTIMAL DRY EYE RELIEF
Fast-acting hydration
Tear evaporation protection
Nano-droplets for better coverage*
#1 DOCTOR RECOMMENDED BRAND1
nano droplet
Alcon
STERILE
10mL (1/3 FL OZ)SIDE PANEL
TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.
Systane®COMPLETE
Our most advanced formula ever!
Systane® COMPLETE Lubricant Eye Drops hydrates fast, protects against tear evaporation, and helps support all layers of the tear film.
Nano droplet technology*
● a better delivery of the active ingredient
● better eye coverage
* vs Systane®BALANCE
1 Based on a survey of eye care professionals. Data on file.
www.alconpatents.com
©2018 Novartis
Made in USA from domestic and imported materials
9015757-0418
Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76143 USA
-
INGREDIENTS AND APPEARANCE
SYSTANE COMPLETE
propylene glycol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-0481 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol .06 mg in 1 mL Inactive Ingredients Ingredient Name Strength Boric Acid (UNII: R57ZHV85D4) Dimyristoylphosphatidylglycerol, Dl- (UNII: BI71WT9P3R) Edetate Disodium (UNII: 7FLD91C86K) Guar Gum (UNII: E89I1637KE) Mineral Oil (UNII: T5L8T28FGP) Polyoxyl 40 Stearate (UNII: 13A4J4NH9I) Sorbitan Tristearate (UNII: 6LUM696811) Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) Hydrochloric Acid (UNII: QTT17582CB) Sodium Hydroxide (UNII: 55X04QC32I) Polidronium Chloride (UNII: 6716Z5YR3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-0481-10 1 in 1 CARTON 01/18/2018 1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:0065-0481-11 2 in 1 CARTON 01/18/2018 2 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:0065-0481-01 1 in 1 CARTON 01/18/2018 3 1.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 4 NDC:0065-0481-55 1 in 1 CARTON 01/18/2018 4 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 5 NDC:0065-0481-72 3 in 1 CARTON 01/18/2018 5 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 01/18/2018 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Alcon Research LLC 007672236 manufacture(0065-0481)