SYSTANE- hypromellose gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Hypromellose 2910 (4000 Mpa.s) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.s) - UNII:RN3152OP35)

Available from:

Alcon Laboratories, Inc.

INN (International Name):

Hypromellose 2910 - UNII:RN3152OP35)

Composition:

Hypromellose 2910 (4000 Mpa.s) 3 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

- for the temporary relief of burning and irritation due to dryness of the eye - for use as a protectant against further irritation or to relieve dryness of the eye - if this product changes color or becomes cloudy - if you are sensitive to any ingredient in this product Stop use and ask a doctor if you experience any of the following: - eye pain - changes in vision - continued redness or irritation of the eye - condition worsens or persists for more than 72 hours

Authorization status:

OTC monograph final

Summary of Product characteristics

SYSTANE- HYPROMELLOSE GEL
ALCON LABORATORIES, INC.
----------
_DRUG FACTS_
_ACTIVE INGREDIENT_
_PURPOSE_
Hypromellose (0.3%)
Lubricant
_USES_
for the temporary relief of burning and irritation due to dryness of
the eye
for use as a protectant against further irritation or to relieve
dryness of the eye
_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
replace cap after using
STOP USE AND ASK A DOCTOR IF you experience any of the following:
eye pain
changes in vision
continued redness or irritation of the eye
condition worsens or persists for more than 72 hours
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
put 1 or 2 drops in the affected eye(s) as needed
_OTHER INFORMATION_
store at room temperature
_INACTIVE INGREDIENTS_
carbopol 980, phosphonic acid, purified water, sodium perborate and
sorbitol. May
contain sodium hydroxide to adjust pH.
_QUESTIONS?_
In the U.S. call 1-800-757-9195
[e-mail]
WWW.SYSTANE.COM
PRINCIPAL DISPLAY PANEL
SYSTANE
LUBRICANT EYE GEL
NIGHT GEL
COMFORTING
DRY EYE RELIEF
LONG LASTING GEL
FOR NIGHTTIME USE
SOOTHING RELIEF
#1 DOCTOR RECOMMENDED BRAND
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
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
®
1
1
25368501
LOT / EXP
SYSTANE
hypromellose gel
PRODUCT 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 29