4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Worsening of Urinary Retention

5.2 Control of Body Temperature

5.3 Operating Machinery or an Automobile

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

7 DRUG INTERACTIONS

7.1 Anticholinergics

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Efficacy and Safety Trials

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information

are not listed

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FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Qbrexza is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatricpatients 9 years of age and older.

2 DOSAGE AND ADMINISTRATION

For topical use only.

Qbrexza is for topical use in the underarm area only and not for use in other body areas.

Qbrexza is administered by a single-use pre-moistened cloth packaged in individual pouches.

Qbrexza should be applied to clean dry skin on the underarm areas only. Qbrexza should not beused more frequently than once every 24 hours.

Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entireunderarm once. Using the same cloth, wipe the other underarm once. A single cloth should be

used to apply Qbrexza to both underarms.

Wash hands immediately with soap and water after applying and discarding the Qbrexza cloth.

Qbrexza may cause temporary dilation of the pupils and blurred vision if it comes in contact withthe eyes. Avoid transfer of Qbrexza to the periocular area [see Warnings and Precautions (5.3)].

Do not apply Qbrexza to broken skin. Avoid using Qbrexza with occlusive dressings.

3 DOSAGE FORMS AND STRENGTHS

Cloth: A single-use cloth pre-moistened with 2.4% glycopyrronium solution

4 CONTRAINDICATIONS

Qbrexza is contraindicated in patients with medical conditions that can be exacerbated by theanticholinergic effect of Qbrexza (e.g., glaucoma, paralytic ileus, unstable cardiovascular status

in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis,myasthenia gravis, Sjogren’s syndrome).

5 WARNINGS AND PRECAUTIONS

5.1 Worsening of Urinary Retention

Qbrexza should be used with caution in patients with a history or presence of documentedurinary retention. Prescribers and patients should be alert for signs and symptoms of urinary

retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatichypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and

consult a physician should any of these signs or symptoms develop.

Patients with a history of urinary retention were not included in the clinical studies.

5.2 Control of Body Temperature