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

Risks and Side Effects

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What is VELTIN Gel?

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 and effective in children under 12 years of age.

Who should not use VELTIN Gel?

Do not use VELTIN Gel if you have:

  • Crohn’s disease
  • ulcerative colitis
  • 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.

What should I tell my doctor before using VELTIN Gel?

Before using VELTIN Gel, tell your doctor if you:

  • have any allergies
  • plan to have surgery with general anesthesia. One of the medicines in VELTIN Gel can affect how certain anesthesia medicines work.
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if VELTIN Gel may harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if VELTIN Gel passes into your breast milk. One of the medicines in VELTIN Gel contains clindamycin. When clindamycin is taken by mouth or injection, it may pass into breast milk. You and your doctor should decide if you will take VELTIN Gel or breast feed. You should not do both.

Tell your doctor about all the medicines and skin products you use. Especially tell your doctor if you take medicine that contains erythromycin. VELTIN Gel should not be used with products that contain erythromycin.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I use VELTIN Gel?
  • Use VELTIN Gel exactly as prescribed.
  • Your doctor will tell you how long to use VELTIN Gel.
  • Do not apply VELTIN Gel more than one time each day.
  • Do not use too much VELTIN Gel, because it may irritate your skin.

Instructions for applying VELTIN Gel:

  1. At bedtime, wash your face gently with a mild soap, rinse with water.
  2. Pat the skin dry.
  3. Squeeze a pea sized amount of medication onto one fingertip. Then, gently rub over the entire affected area. Do not get VELTIN Gel in your eyes, mouth, or on your lips.
What should I avoid while using VELTIN Gel?
  • Limit your time in sunlight. Avoid using tanning beds or sun lamps. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing. Apply a sunscreen every morning and re-apply during the day as needed.
  • Avoid wind and cold weather during treatment with VELTIN Gel. These may be irritating to your skin.
  • Avoid using abrasive soaps and cleansers. These may cause increased skin irritation with VELTIN Gel.
What are the possible side effects of VELTIN Gel?

VELTIN Gel may cause serious side effects, including:

  • Inflammation of the colon (colitis). Clindamycin, one of the ingredients in VELTIN Gel, can cause severe colitis that may lead to death. Stop taking VELTIN Gel and call your doctor if you develop severe watery diarrhea, or bloody diarrhea.
  • Sunburn. VELTIN Gel may cause your skin to become sunburned more easily. If your face is sunburned, do not use VELTIN Gel until your sunburn is completely healed. Tretinoin, one of the medicines in VELTIN Gel, makes your skin more sensitive to sunlight. See "What should I avoid while using VELTIN Gel?"

Common side effects of VELTIN Gel include:

  • Skin irritation. VELTIN Gel may cause skin irritation such as dryness, peeling, burning, or itching.

Talk to your doctor about any side effect that bothers you or that does not go away.
These are not all the side effects with VELTIN Gel. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

General information about VELTIN Gel

Medicines are sometimes prescribed for purposes other than those listed in the patient information leaflet. Do not use VELTIN Gel for a condition for which it was not prescribed. Do not give VELTIN Gel to other people, even if they have the same symptoms you have. It may harm them.

This summarizes the most important information about VELTIN Gel. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about VELTIN Gel that is written for healthcare professionals.

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

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.