Drugplain

BOTOX Cosmetic 100 [USP'U]/1

onabotulinumtoxinA · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Allergan, Inc.

No Recall History
Plain English

Botox Cosmetic is an injectable medication that works by blocking acetylcholine release to temporarily relax facial muscles and reduce the appearance of wrinkles. It is administered by intramuscular injection and is used cosmetically to smooth dynamic facial lines, particularly on the forehead, between the eyebrows, and around the eyes.

Key Facts

Brand Name
BOTOX Cosmetic
Generic Name
onabotulinumtoxinA
NDC Code (Product)
0023-9232
Manufacturer
Allergan, Inc.
Strength
100 [USP'U]/1
Dosage Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Marketing Status
Application #
BLA103000
Drug Class
Acetylcholine Release Inhibitor [EPC]; Neuromuscular Blocker [EPC]
Marketing Start
05/20/2008

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective20,319 reports
off label use5,780 reports
therapeutic response decreased3,691 reports
product preparation error3,261 reports
multiple use of single-use product2,610 reports
injection site pain2,043 reports
eyelid ptosis1,905 reports
wrong technique in drug usage process1,462 reports
headache1,455 reports
wrong technique in product usage process1,265 reports

Frequently Asked Questions

What is BOTOX Cosmetic used for?

Botox Cosmetic is an injectable medication that works by blocking acetylcholine release to temporarily relax facial muscles and reduce the appearance of wrinkles. It is administered by intramuscular injection and is used cosmetically to smooth dynamic facial lines, particularly on the forehead, between the eyebrows, and around the eyes.

Is BOTOX Cosmetic a controlled substance?

BOTOX Cosmetic is not classified as a controlled substance by the DEA.

What is the generic name for BOTOX Cosmetic?

The generic name for BOTOX Cosmetic is onabotulinumtoxinA. There are 3 other brand versions of onabotulinumtoxinA.

What is the NDC code for BOTOX Cosmetic 100 [USP'U]/1?

The NDC (National Drug Code) for BOTOX Cosmetic 100 [USP'U]/1 is 0023-9232, listed by Allergan, Inc..

Product NDC

0023-9232

Package NDC

0023-9232-01

Other BOTOX Cosmetic Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)