Label: SYSTANE- hypromellose gel
- NDC Code(s): 0065-0474-01, 0065-0474-02
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- 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®
LUBRICANT EYE GEL
NIGHT GEL
COMFORTING
DRY EYE RELIEF
Long lasting gel
for nighttime use
Soothing relief
#1 DOCTOR RECOMMENDED BRAND1
GEL
Alcon
STERILE 10g
(0.35 OZ)
TAMPER EVIDENT: For your
protection, use only if pull tab is
intact at time of purchase.
www.alconpatents.com
1 Based on a survey of eye care
professionals. Data on file.
Processed in France with
US-origin active ingredient for:
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
25368501-0519
25368501LOT / EXP
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INGREDIENTS AND APPEARANCE
SYSTANE
hypromellose gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-0474 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hypromellose 2910 (4000 Mpa.s) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.s) - UNII:RN3152OP35) Hypromellose 2910 (4000 Mpa.s) 3 mg in 1 g Inactive Ingredients Ingredient Name Strength Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E) Phosphonic Acid (UNII: 35V6A8JW8E) Water (UNII: 059QF0KO0R) Sodium Perborate (UNII: Y52BK1W96C) Sorbitol (UNII: 506T60A25R) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-0474-01 1 in 1 CARTON 12/15/2012 1 10 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0065-0474-02 1 in 1 CARTON 12/15/2012 12/31/2018 2 3.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 12/15/2012 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Excelvision 274234566 manufacture(0065-0474) , label(0065-0474) , pack(0065-0474) Establishment Name Address ID/FEI Business Operations SERVIPACK 571772875 label(0065-0474) , pack(0065-0474)