Label: SYSTANE COMPLETE PF- propylene glycol solution/ drops
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- NDC Code(s): 0065-1530-01
- 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 September 9, 2021
If you are a consumer or patient please visit this version.
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- 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
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Warnings
For external use only
Do not use
- if this product changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
When using this product
- do not touch tip of container to any surface to avoid contamination
- do not reuse
- once opened, discard
- Directions
- Other Information
- Inactive Ingredients
- Questions?
-
PRINCIPAL DISPLAY PANEL
SAMPLE-NOT FOR SALE
Systane®
LUBRICANT EYE DROP
COMPLETE PF
PRESERVATIVE-FREE
DRY EYE RELIEF
Fast-acting hydration for sensitive eyes
Tear evaporation protection
Nano-droplets for better coverage*
Only available at retail in a preservative-free bottle
#1 DOCTOR RECOMMENDED BRAND1
Alcon
STERILE
5 Vials 0.5 mL (0.01 FL OZ) each
Side Panel:
Exclusive Formula Not Sold in Store Brands
DIRECTIONS: Make sure container is intact before use.
To open, COMPLETELY TWIST OFF TAB. Do not pull off. Put 1 or 2 drops in the affected eye(s) as needed.
Throw away container. Do not reuse.
TAMPER EVIDENT: For your protection, do not use if vial is damaged or opened.
437600
1Based on a survey of eye care professionals.
Data on file.
*vs SYSTANE® BALANCE
LOT :
EXP:
2737
-
INGREDIENTS AND APPEARANCE
SYSTANE COMPLETE PF
propylene glycol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-1530 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) Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-1530-01 5 in 1 CARTON 02/01/2022 1 0.5 mL in 1 VIAL, SINGLE-DOSE; 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 02/01/2022 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Kaysersberg Pharmaceuticals 267486052 manufacture(0065-1530)