Approved Uses
BOTOX® Cosmetic is a prescription medicine that is injected into
muscles and used to temporarily improve the look of moderate to
severe forehead lines, crow’s feet lines, and frown lines between
the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can
be life threatening. Get medical help right away if you
have any of these problems any time (hours to weeks)
after injection of BOTOX® Cosmetic:
• Problems swallowing, speaking, or breathing, due to
weakening of associated muscles, can be severe and result in
loss of life. You are at the highest risk if these problems are
pre-existing before injection. Swallowing problems may last
for several months.
• Spread of toxin effects. The effect of botulinum toxin may
affect areas away from the injection site and cause serious
symptoms including: loss of strength and all-over muscle
weakness, double vision, blurred vision and drooping eyelids,
hoarseness or change or loss of voice, trouble saying words
clearly, loss of bladder control, trouble breathing, and trouble
swallowing.
BOTOX® Cosmetic dosing units are not the same as, or
comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin
effect when BOTOX® Cosmetic has been used at the recommended
dose to treat frown lines, crow’s feet lines, and/or forehead lines.
BOTOX® Cosmetic may cause loss of strength or general muscle
weakness, vision problems, or dizziness within hours to weeks of
taking BOTOX® Cosmetic. If this happens, do not drive a car,
operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been
reported. They include: itching, rash, red itchy welts, wheezing,
asthma symptoms, or dizziness or feeling faint. Get medical help
right away if you are wheezing or have asthma symptoms, or if you
become dizzy or faint.
Do not receive BOTOX® Cosmetic if you: are allergic to any
of the ingredients in BOTOX® Cosmetic (see Medication Guide
for ingredients); had an allergic reaction to any other botulinum
toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport®
(abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a
skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions,
such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-
Eaton syndrome, as you may be at increased risk of serious side
effects including difficulty swallowing and difficulty breathing
from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions,
including: plans to have surgery; had surgery on your face;
have trouble raising your eyebrows; drooping eyelids; any
other abnormal facial change; are pregnant or plan to become
pregnant (it is not known if BOTOX® Cosmetic can harm your
unborn baby); are breast-feeding or plan to (it is not known if
BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and
herbal supplements. Using BOTOX® Cosmetic with certain other
medicines may cause serious side effects. Do not start any new
medicines until you have told your doctor that you have
received BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin
product in the last 4 months; have received injections of botulinum
toxin such as in the past Myobloc®, Dysport®, or Xeomin® (tell your
doctor exactly which product you received); have recently received
an antibiotic by injection; take muscle relaxants; take an allergy or
cold medicine; take a sleep medicine; take aspirin-like products or
blood thinners.