Tersi Foam

Name: Tersi Foam

What do I need to tell my doctor BEFORE I take Tersi Foam?

  • If you have an allergy to selenium sulfide or any other part of Tersi Foam (selenium sulfide foam).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tersi Foam?

  • Tell all of your health care providers that you take Tersi Foam. This includes your doctors, nurses, pharmacists, and dentists.
  • If you use this medicine too often, your skin problem may become worse.
  • Talk with your doctor before you use other drugs or products on your skin.
  • Do not put on irritated skin.
  • Do not put on open sores or broken skin.
  • This medicine may cause harm if swallowed. If Tersi Foam is swallowed, call a doctor or poison control center right away.
  • This medicine may catch on fire. Do not use near an open flame or while smoking.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Tersi Foam) best taken?

Use Tersi Foam as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Shake well before use.
  • Take off jewelry before use.
  • Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
  • Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
  • Put on affected part and rub gently.
  • Leave on the skin for as long as the doctor told you to, then wash off.

What do I do if I miss a dose?

  • Put on a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not put on 2 doses at the same time or extra doses.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Tersi Foam, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tersi Foam. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Tersi Foam (selenium sulfide foam).

Review Date: October 4, 2017

Tersi Foam - Clinical Pharmacology

Topically applied selenium sulfide appears to have a cytostatic effect on cells of the epidermis, reducing corneocyte production.

PHARMACOKINETICS

The mechanism of action of topically applied selenium sulfide is not yet known. 

Contraindications

Known hypersensitivity to any of the listed ingredients.

Precautions

TERSI should be used only as directed by a physician and should not be used to treat any condition other than that for which it is prescribed.TERSI should not be used on any skin area where inflammation or exudation is present as increased absorption may occur. If redness or irritation occurs, discontinue use and consult with prescribing physician.

Pregnancy (Category C)

Animal reproduction studies have not been performed with topically applied selenium sulfide and it is not known whether TERSI can cause fetal harm when administered to a pregnant woman. Nevertheless, TERSI should be used by a pregnant woman only if necessary. 

Nursing Mothers

It is not known whether topically applied selenium sulfide is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering TERSI to nursing mothers. 
KEEP THIS AND ALL OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN.

Tersi Foam Dosage and Administration

Unless otherwise directed by a prescribing physician,TERSI should be applied to affected area twice a day.TERSI should be rubbed into the skin until it is completely absorbed.

TERSI should be shaken vigorously before each application and inverted to administer.

Folding Carton

TERSI 
selenium sulfide aerosol, foam
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:23710-225
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELENIUM SULFIDE (SELENIUM) SELENIUM SULFIDE 1.44 g  in 70 g
Inactive Ingredients
Ingredient Name Strength
POVIDONE K29/32  
STEARIC ACID  
PROPYLENE GLYCOL  
GLYCERIN  
DIMETHICONE  
POLYSORBATE 20  
ETHYLPARABEN  
PROPYLPARABEN  
PHENOXYETHANOL  
METHYLPARABEN  
WATER  
TROLAMINE  
Packaging
# Item Code Package Description
1 NDC:23710-225-70 70 g in 1 CANISTER
2 NDC:23710-225-01 10 g in 1 CANISTER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/01/2009
Labeler - Quinnova Pharmaceuticals, Inc. (607183766)
Revised: 12/2009   Quinnova Pharmaceuticals, Inc.

For the Consumer

Applies to selenium sulfide topical: topical cream, topical foam, topical lotion, topical shampoo, topical suspension

Along with its needed effects, selenium sulfide topical (the active ingredient contained in Tersi Foam) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking selenium sulfide topical:

Less common or rare
  • Skin irritation

Some side effects of selenium sulfide topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Unusual dryness or oiliness of hair or scalp
Less common
  • Increase in normal hair loss

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