IMPORTANT SAFETY INFORMATION for VELTIN Gel

Do not use VELTIN Gel if you have Crohn’s disease or ulcerative colitis, or have had inflammation of the colon (colitis) with past antibiotic use. Talk to your doctor if you are not sure if you have one of these conditions. SAFETY INFORMATION CONTINUED BELOW

About VELTIN Gel

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VELTIN Gel is a prescription medicine used on the skin to treat acne in people 12 years and older. VELTIN Gel is a water-based, alcohol-free formulation of 2 acne-fighting medicines.

With once-a-day application, VELTIN Gel may fit into your routine. Just talk to your doctor to see if VELTIN Gel is right for you.

VELTIN Gel is prescription medicine used on the skin to treat acne in people 12 years and older.

It is not known if VELTIN Gel is safe or effective in children under 12 years of age.

IMPORTANT: VELTIN Gel is for use only on your skin. Do not get VELTIN Gel in your mouth, eyes, or vagina.

Important Safety Information for VELTIN Gel

Do not use VELTIN Gel if you have Crohn's disease or ulcerative colitis, or have had inflammation of the colon (colitis) with past antibiotic use. Talk to your doctor if you are not sure if you have one of these conditions.

Clindamycin, one of the ingredients in VELTIN Gel, can cause severe colitis that may lead to death. Topical clindamycin may be absorbed through the skin into the bloodstream. Diarrhea, bloody diarrhea, and colitis have been reported with the use of topical clindamycin. Stop using VELTIN Gel and call your doctor if you develop severe watery diarrhea or bloody diarrhea.

While using VELTIN Gel, limit your time in the sun and avoid tanning beds and sunlamps. VELTIN Gel may cause your skin to become sunburned more easily. If you have a sunburn, do not use VELTIN Gel until it is healed. Use sunscreen and protective clothing, such as a hat. Also avoid other weather extremes such as wind and cold temperatures because these may be irritating to your skin.

Common side effects of VELTIN Gel include skin irritation (for example dryness, peeling, burning, or itching), which usually decreases gradually after 2 weeks.

Tell your doctor if you have any allergies or any other medical conditions.

Before using VELTIN Gel, tell your doctor if you plan to have surgery with general anesthesia. One of the medicines in VELTIN Gel can affect how certain anesthesia medicines work.

Tell your doctor if you are pregnant or plan to become pregnant, as it is not known if VELTIN Gel may harm your unborn baby.

It is not known if VELTIN Gel passes into breast milk. Topical clindamycin may be absorbed through the skin into the bloodstream. Clindamycin may pass into the breast milk when taken by mouth or by injection. You and your doctor should decide if you will use VELTIN Gel or breast-feed. You should not do both.

VELTIN Gel should not be used with products that contain erythromycin. Tell your doctor if you take medicine that contains erythromycin.

For more information about VELTIN Gel, please see the full Prescribing Information.