12 Ketotifen (0.025%) (equiv. to ketotifenketotifen fumarate ophthalmic solution ANTIHISTAMINE EYE...
4
Do not use if seal on bottle is missing or broken. Made in Canada for: Novartis Pharmaceuticals Corp. East Hanover, NJ 07936 © Novartis www.ZADITOR.com ketotifen fumarate ophthalmic solution 0078-9475-61 0078-9475-61 ANTIHISTAMINE EYE DROPS for ages 3 years and older 1 mL (0.03 FL OZ) ® Sterile SAMPLE NOT FOR SALE • Works in Minutes • Or iginal Prescription Strength • Works in Minutes • Original Prescription Strength ketotifen fumarate ophthalmic solution K758D6 K758D6 12 HOURS 12 HOURS up to up to EYE ITCH RELIEF Drug Facts Active ingredient Purpose Ketotifen (0.025%) (equiv. to ketotifen fumarate 0.035%)................ Antihistamine Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander. Warnings Do not use ■ if solution changes color or becomes cloudy ■ if you are sensitive to any ingredient in this product ■ to treat contact lens related irritation Drug Facts (continued) When using this product ■ do not touch tip of container to any surface to avoid contamination ■ remove contact lenses before use ■ wait at least 10 minutes before reinserting contact lenses after use ■ replace cap after each use Stop use and ask a doctor if you experience any of the following: ■ eye pain ■ changes in vision ■ redness of the eye ■ itching worsens or lasts 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 ■ Children under 3 years of age: Consult a doctor. Inactive ingredients benzalkonium chloride 0.01%, glycerol, sodium hydroxide and/or hydrochloric acid, and purified water Questions? call toll-free 1-866-393-6336, weekdays, 8:30 AM - 5:00 PM EST Directions ■ Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. Other information ■ Only for use in the eye. ■ Store between 4°-25°C (39°-77°F). Drug Facts (continued)
Transcript of 12 Ketotifen (0.025%) (equiv. to ketotifenketotifen fumarate ophthalmic solution ANTIHISTAMINE EYE...
Do not use if seal on bottleis missing or broken.
Made in Canada for:Novartis Pharmaceuticals Corp.
East Hanover, NJ 07936© Novartis
www.ZADITOR.com
Material Group No.:
• ZNV
•
•
Dimensions:
Component No.:
• K758D6
•
•
Supersedes Component No.:
• NEW
•
•
Number of Colors: 4 Color Process: CMYK
Description: Zaditor OTC 1 mL Sample Carton
FPO - For Position Only - Do Not PrintDo Not Print Dotted Lines
LD&C: ___________________________________________ Date: ________________
LD&C: ___________________________________________ Date: ________________
Engineer: _________________________________________ Date: _______________
ketotifen fumarate ophthalmic solution
0078-9475-610078-9475-61
ANTIHISTAMINE EYE DROPS
for ages 3 years and older
1 mL (0.03 FL OZ)
®
Sterile
SAMPLENOT FOR SALE
• Works in Minutes• Original Prescription Strength• Works in Minutes• Original Prescription Strength
ketotifen fumarate ophthalmic solution
K758D6
K75
8D6
12HOURS12
HOURS
up toup toEYE ITCHRELIEF
Use PANTONE MATCHING SYSTEM for an accurate color representation.
TARGET COLORS
Dru
g Fa
cts
Activ
e in
gred
ient
Purp
ose
Keto
tifen
(0.0
25%
) (eq
uiv.
to k
etot
ifen
fum
arat
e 0.
035%
).....
......
.....
Antih
istam
ine
Use
Tem
pora
rily
relie
ves
itchy
eye
s du
e to
pol
len,
ragw
eed,
gra
ss, a
nim
al h
air
and
dand
er.
War
ning
sDo
not
use
■ if
solut
ion ch
ange
s colo
r or b
ecom
es cl
oudy
■ if
you
are
sens
itive
to a
ny in
gred
ient in
this
prod
uct
■ to
trea
t con
tact
lens r
elate
d irr
itatio
n
Drug
Fac
ts (c
ontin
ued)
Whe
n us
ing
this
pro
duct
■
do
not t
ouch
tip o
f con
taine
r to
any s
urfa
ce to
avo
idco
ntam
inatio
n ■
rem
ove
cont
act le
nses
bef
ore
use
■ w
ait a
t leas
t 10
minu
tes b
efor
e re
inser
ting
cont
act le
nses
afte
r use
■ re
place
cap
afte
r eac
h us
eSt
op u
se an
d as
k a d
octo
r if y
ou ex
perie
nce a
ny of
the f
ollow
ing:
■ ey
e pa
in■
chan
ges i
n visi
on ■
redn
ess o
f the e
ye ■
itchin
g wor
sens
or la
sts fo
r mor
e tha
n 72 h
ours
Keep
out
of r
each
of c
hild
ren.
If sw
allow
ed, g
et m
edica
l hel
p or
con
tact
a
Poiso
n Co
ntro
l Cen
ter r
ight
awa
y.
Dire
ctio
ns ■
Chi
ldre
n un
der 3
year
s of a
ge: C
onsu
lt a d
octo
r.
Inac
tive i
ngre
dien
ts b
enza
lkoniu
m ch
loride
0.0
1%, g
lycer
ol, so
dium
hydr
oxide
an
d/or
hydr
ochlo
ric a
cid, a
nd p
urifie
d wa
ter
Ques
tions
? ca
ll toll
-free
1-86
6-39
3-63
36, w
eekd
ays,
8:30
AM
- 5:
00 P
M E
ST
Dire
ctio
ns
■ A
dults
and c
hildr
en 3
year
s of a
ge an
d olde
r: Pu
t 1 dr
op in
the
affec
ted ey
e(s)
twice
dail
y, ev
ery 8
-12
hour
s, no
mor
e th
an tw
ice p
er d
ay.
Othe
r inf
orm
atio
n ■
Only
for u
se in
the e
ye.
■ S
tore b
etwee
n 4°-2
5°C
(39°
-77°
F).
Drug
Fac
ts (c
ontin
ued)
ketotifen fumarate ophthalmic solutionketotifen fumarate ophthalmic solutionANTIHISTAMINE EYE DROPS
Do not use if seal on bottleis missing or broken.
0 00000 00000 00 00000 00000 0
5 mL (0.17 FL OZ) Sterile
NDC 0078-0476-61NDC 0078-0476-61
Original PrescriptionStrength
•Up to 12 Hour
Itch Relief
Works in Minutes
•For Ages
3 Years and Older
®
for ages 3 years and older30 day supply
®
K759D6
Made in Canada for:Novartis Pharmaceuticals Corp.
East Hanover, NJ 07936© Novartis
www.ZADITOR.com
K759D
6
• Works in Minutes• Original Prescription Strength
12HOURS12
HOURS
up toup toEYE ITCHRELIEF 30 DAY SUPPLY
Material Group No.:
• ZNV
•
•
Dimensions:
Component No.:
• K759D6
•
•
Supersedes Component No.:
• NEW
•
•
Number of Colors: 4 Color Process: CMYK
Description: Zaditor OTC 5 mL Trade Carton
FPO - For Position Only - Do Not PrintDo Not Print Dotted Lines
LD&C: ___________________________________________ Date: ________________
LD&C: ___________________________________________ Date: ________________
Engineer: _________________________________________ Date: _______________
Use PANTONE MATCHING SYSTEM for an accurate color representation.
TARGET COLORS
Drug FactsActive ingredient PurposeKetotifen (0.025%) ................................ Antihistamine(equivalent to ketotifen fumarate 0.035%)
UseTemporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
WarningsDo not use■ if solution changes color or becomes cloudy■ if you are sensitive to any ingredient in this product■ to treat contact lens related irritation
When using this product■ do not touch tip of container to any surface to avoid contamination ■ remove contact lenses before use■ wait at least 10 minutes before reinserting contact lenses after use ■ replace cap after each useStop use and ask a doctor if you experienceany of the following: ■ eye pain ■ changes in vision ■ redness of the eye■ itching worsens or lasts for more than 72 hoursKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Other information ■ Only for use in the eye.■ Store between 4°-25°C (39°-77°F).
■ Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.■ Children under 3 years of age: Consult a doctor.
Drug Facts (continued)Inactive ingredients benzalkonium chloride 0.01%, glycerol, sodium hydroxide and/or hydrochloric acid, and purified water
Questions?call toll-free 1-866-393-6336, weekdays, 8:30 AM - 5:00 PM EST
1 mL (0.03 FL OZ) SterileSAMPLE -- NOT FOR SALE
Only
for us
e in t
he ey
e. St
ore b
etwee
n 4°-2
5°C
(39°
-77°
F). D
o not
use
if sea
l on b
ottle
ismi
ssing
or br
oken
.Ma
de in
Cana
da fo
r:No
varti
s Pha
rm. C
orp.
East
Hano
ver, N
J 079
36©
Nova
rtis
ketotifen fumarateophthalmic solution
ANTIHISTAMINE EYE DROPS00
78-9
475-
61
G75
8D6
G75
8D6
®
Only
for us
e in t
he ey
e. St
ore b
etwee
n 4°-2
5°C
(39°
-77°
F). D
o not
use
if sea
l on b
ottle
ismi
ssing
or br
oken
.Ma
de in
Cana
da fo
r:No
varti
s Pha
rm. C
orp.
East
Hano
ver, N
J 079
36©
Nova
rtis
0078
-947
5-61
1 mL (0.03 FL OZ) SterileSAMPLE -- NOT FOR SALE
ketotifen fumarateophthalmic solution
ANTIHISTAMINE EYE DROPS
®
1/4" no print / no varnish 3/4" no print / no varnish
Lot # and expiration dateimprinted here
Material Group No.:
• ZNV
•
•
Dimensions:
Component No.:
• G758D6
•
•
Supersedes Component No.:
• NEW
•
•
Number of Colors: 2 PMS 1595Black
Description: Zaditor OTC 1 mL Sample Label
FPO - For Position Only - Do Not PrintDo Not Print Dotted Lines
LD&C: ___________________________________________ Date: ________________
LD&C: ___________________________________________ Date: ________________
Engineer: _________________________________________ Date: _______________
200%
200%
G75
9D6
Only for use in the eye. Store between 4°-25°C (39°-77°F).Do not use if seal on bottle is missing or broken.Made in Canada for:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936© Novartis
NDC 0078-0476-61
ketotifen fumarateophthalmic solution
®
5 mL (0.17 FL OZ) Sterile
Only for use in the eye. Store between 4°-25°C (39°-77°F).Do not use if seal on bottle is missing or broken.Made in Canada for:Novartis Pharmaceuticals Corp.East Hanover, NJ 07936© Novartis
G75
9D6
ANTIHISTAMINE EYE DROPS
1/4" no print / no varnish
3/8" no print / no varnish# and expiration dateimprinted here
PMS 1595C
Material Group No.:
• ZNV
•
•
Dimensions:
Component No.:
• G759D6
•
•
Supersedes Component No.:
• NEW
•
•
Number of Colors: 2 PMS 1595Black
Description: Zaditor OTC 5 mL Trade Label
FPO - For Position Only - Do Not PrintDo Not Print Dotted Lines
LD&C: ___________________________________________ Date: ________________
LD&C: ___________________________________________ Date: ________________
Engineer: _________________________________________ Date: _______________
NDC 0078-0476-61
ketotifen fumarateophthalmic solution
®
5 mL (0.17 FL OZ) SterileANTIHISTAMINE EYE DROPS
