Get ready for
Sofdra™ (sofpironium) topical gel, 12.45%

Now FDA‑Approved

Introducing Sofdra, a prescription anticholinergic medicine used on the skin (topical) to treat excessive underarm sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older. Be the first to know when Sofdra is available. Sign up below.

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Important Safety Information & Indication

Indication

Sofdra (sofpironium) topical gel, 12.45% is a prescription anticholinergic medicine used on the skin (topical) to treat excessive underarm sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older.

IMPORTANT SAFETY INFORMATION

Sofdra is for use on the skin in the underarm area only. Wash your hands right away after you apply Sofdra. Do not touch your underarms after applying Sofdra. Sofdra is flammable. Avoid heat and flame while applying Sofdra.

**Who should not use Sofdra?**

Do not use Sofdra if you have certain medical conditions that can be made worse by taking an anticholinergic medicine such as glaucoma, severe ulcerative colitis (UC) or certain other serious bowel problems associated with severe UC, myasthenia gravis, and Sjogren's syndrome.

**What should I tell my healthcare provider before using Sofdra?**

Tell your healthcare provider about all of your medical conditions, including bladder or kidney problems, problems passing urine, if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. It is not known if Sofdra will harm your unborn baby or pass into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, especially any anticholinergic medicines.

**What are possible side effects of Sofdra?**

Serious side effects may include:

Blurred vision. Stop using Sofdra, call your healthcare provider right away, and do not drive or operate machinery or do hazardous work until your vision is clear.
New or worsened urinary retention. Stop using Sofdra and call your healthcare provider right away if you experience difficulty urinating, urinating frequently, urination in a weak stream or drips, full bladder or difficulty emptying your bladder.

The most common side effects of Sofdra include dry mouth; blurred vision; pain, redness, swelling, itching, and irritation in the underarm area; dilation of the pupils of your eyes (mydriasis); and problems with urination. These are not all of the possible side effects of Sofdra. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to Botanix at 1‑866‑763‑6337.

Keep Sofdra and all medicines out of the reach of children.

Please see full Prescribing Information and Patient Product Information.

Get ready forSofdra™ (sofpironium) topical gel, 12.45%