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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Xtracare Antibacterial Hand Cleanse
Generic Name
Triclosan
Active Ingredient
TriclosanCategory
Other
Variants
4
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Xtracare Antibacterial Hand Cleanse, you must consult a qualified healthcare professional.
| 3.3 mg/221mL | SOAP | TOPICAL | 57337-023 |
Detailed information about Xtracare Antibacterial Hand Cleanse
Triclosan is a broad-spectrum antibacterial and antifungal agent historically used in consumer soaps and still utilized in specific dental products and medical devices to prevent microbial contamination.
Because Triclosan is primarily found in topical and dental products rather than systemic medications, 'dosage' refers to the frequency and concentration of application.
For the reduction of plaque and gingivitis, the standard adult protocol involves using a toothpaste containing 0.3% Triclosan. Healthcare providers typically recommend brushing thoroughly twice daily (morning and night) for at least two minutes. It is important to ensure that the toothpaste reaches all areas of the gums, as the antimicrobial effect is localized to the site of application.
In the context of surgical sutures, the dosage is pre-determined by the manufacturer of the medical device. The amount of Triclosan is calibrated to provide a zone of inhibition around the wound site for several days following the procedure. Patients do not need to take any action regarding the 'dose' of these sutures.
For children aged 6 years and older, the use of Triclosan-containing toothpaste should follow the same twice-daily schedule as adults, but under strict supervision to minimize swallowing. A pea-sized amount is generally recommended.
For children under the age of 6, Triclosan-containing toothpastes are generally not recommended unless specifically directed by a dentist or pediatrician. This is due to the increased risk of systemic absorption through swallowing and the lack of robust safety data for this specific age group regarding long-term exposure.
Because Triclosan is excreted via the kidneys, there has been theoretical concern regarding accumulation in patients with severe renal failure. However, since the amount absorbed from toothpaste or sutures is minimal, standard clinical practice does not currently require dose adjustments for patients with kidney disease. Patients on dialysis should still consult their nephrologist before using any products with significant systemic absorption potential.
As the liver is responsible for the conjugation and detoxification of Triclosan, individuals with advanced cirrhosis or liver failure may process the compound more slowly. While topical use is generally considered safe, these patients should be monitored for any unusual skin reactions or systemic sensitivities.
No specific dosage adjustments are required for geriatric patients. However, older adults often have thinner skin (increasing absorption) and may be taking multiple other medications. Healthcare providers should assess the overall chemical burden in elderly patients who use multiple antimicrobial products.
Products containing Triclosan should be stored at room temperature, typically between 68°F and 77°F (20°C to 25°C). Keep the containers tightly closed when not in use to prevent the product from drying out or becoming contaminated.
If you miss a scheduled brushing with Triclosan toothpaste, simply resume your normal schedule at the next designated time. Do not use double the amount of toothpaste to 'make up' for a missed session. Consistency is more important than the volume of product used for maintaining gum health.
Acute overdose of Triclosan via topical application is virtually impossible. However, accidental ingestion of large quantities of Triclosan-containing toothpaste (especially by children) can occur.
> Important: Follow your healthcare provider's dosing instructions and the specific directions on the product label. Do not adjust your use of antimicrobial products without medical guidance.
Triclosan is generally well-tolerated when used as directed in dental and topical applications. However, some users may experience mild localized reactions:
Triclosan is intended for external or localized use only. It should never be ingested in significant quantities. The most important safety consideration for patients today is understanding where Triclosan is still found and why it was removed from other products. Patients should be aware that 'antibacterial' does not always mean 'better,' and for routine handwashing, the CDC and FDA recommend plain soap and water over antimicrobial products containing Triclosan.
No FDA black box warnings for Triclosan. The regulatory actions taken by the FDA in 2016 and 2019 are 'Final Rules' regarding the marketing of OTC antiseptic products, not specific black box warnings on a prescription label.
Individuals with a known hypersensitivity to Triclosan or other chlorinated phenols should avoid all products containing this ingredient. While rare, systemic allergic reactions can occur. If you have a history of reacting to various cosmetics or preservatives, a 'patch test' (applying a small amount to the inner forearm) is recommended before widespread use.
There are no documented 'absolute' drug-drug contraindications for Triclosan because its systemic levels remain very low. However, it should not be used simultaneously with other potent topical halogenated compounds unless directed by a doctor, as this may increase the risk of severe skin irritation.
There is chemical evidence that Triclosan can react with the free chlorine found in tap water to produce small amounts of chloroform, a known carcinogen. While the levels produced during a typical handwash or tooth-brushing session are extremely low, this chemical interaction is a point of concern for long-term environmental and personal health.
If you are applying topical corticosteroids to treat eczema or psoriasis, using a Triclosan-containing cleanser on the same area may increase the penetration of the steroid or, conversely, cause excessive irritation. It is best to apply these products at different times or consult a dermatologist.
Triclosan must NEVER be used by individuals with a documented allergy to the compound or to other phenols (such as triclocarban). The mechanism of contraindication is an IgE-mediated or T-cell mediated immune response, which can lead to severe dermatitis or anaphylaxis.
As of 2016, Triclosan is 'contraindicated' for use in over-the-counter consumer antiseptic washes. This is not due to an immediate toxic reaction, but because the FDA determined that these products are not 'Generally Recognized as Safe and Effective' (GRASE) for long-term daily use in the absence of clinical evidence showing superiority over plain soap.
While not strictly forbidden, many clinicians advise a risk-benefit analysis for pregnant women due to Triclosan's status as a suspected endocrine disruptor. If a non-Triclosan alternative is available for gingivitis management, it may be preferred during pregnancy.
Triclosan has been detected in human umbilical cord blood and amniotic fluid, confirming that it crosses the placental barrier. Animal studies have shown that high doses of Triclosan can interfere with the activity of an enzyme called estrogen sulfotransferase, which is vital for the metabolism of estrogen and the maintenance of a healthy pregnancy. While there is no definitive evidence of teratogenicity (birth defects) in humans, the potential for endocrine disruption has led many experts to recommend minimizing exposure during pregnancy. Pregnant women should discuss the necessity of Triclosan-containing toothpaste with their obstetrician and dentist.
Triclosan is lipophilic (fat-soluble) and is known to pass into human breast milk. Studies have detected varying concentrations of Triclosan in the milk of nursing mothers, correlating with their use of products containing the ingredient. While the levels are generally low, the long-term effects on a developing infant's endocrine system and microbiome are not fully understood. Nursing mothers should weigh the benefits of using Triclosan for gum health against the potential for infant exposure.
Triclosan is a specific, 'target-site' antimicrobial. Its primary mechanism involves the inhibition of the bacterial enzyme enoyl-acyl carrier protein reductase (FabI). This enzyme is essential for the final step of each cycle of fatty acid elongation in the bacterial Type II fatty acid synthesis (FAS-II) pathway. By binding to the FabI-NAD+ complex, Triclosan prevents the reduction of the enoyl-ACP substrate. This leads to a depletion of the fatty acids required for the synthesis of the bacterial cell membrane.
At low concentrations, Triclosan is bacteriostatic (it stops bacteria from growing). At higher concentrations, it can act as a bactericidal agent by causing gross disruption of the bacterial cytoplasmic membrane and leakage of cellular contents. It is effective against a wide range of bacteria, including Staphylococcus aureus, Escherichia coli, and various Streptococcus species found in the mouth.
The pharmacodynamic effect of Triclosan is characterized by its high substantivity. When applied to the teeth and gums, it remains active for up to 12 hours. The dose-response relationship is well-established in dental literature: a 0.3% concentration is significantly more effective than 0.1% for the reduction of gingivitis, while concentrations above 0.3% do not provide a proportional increase in benefit but do increase the risk of irritation.
Common questions about Xtracare Antibacterial Hand Cleanse
Triclosan is primarily used as an antibacterial and antifungal agent to prevent the growth of microbes. In the current clinical landscape, its most common FDA-approved use is in toothpaste to help prevent gingivitis, plaque, and gum bleeding. It is also used in medical settings as a coating for surgical sutures to reduce the risk of surgical site infections. Historically, it was a common ingredient in antibacterial hand soaps, but this use was restricted by the FDA in 2016 for consumer products. Always check the labels of your personal care products to see if they contain this active ingredient.
The most common side effects associated with Triclosan are localized and mild. When used in toothpaste, some individuals may experience minor oral irritation, a temporary dry mouth sensation, or a slight change in taste. When used in topical creams or deodorants, it can occasionally cause skin redness, itching, or mild contact dermatitis. Most of these symptoms resolve quickly once the product is no longer in contact with the body. If you experience persistent irritation or a rash, you should discontinue use and consult a healthcare professional.
There are no known direct contraindications between drinking alcohol and using Triclosan-containing products like toothpaste or sutures. Since Triclosan is applied topically or used in the mouth and not taken as a systemic pill, it does not interact with alcohol in the liver in a way that would cause danger. However, using alcohol-based mouthwashes alongside Triclosan toothpaste might increase oral dryness for some people. It is always best to maintain a moderate approach to alcohol for overall health. If you have specific concerns, your dentist or doctor can provide personalized advice.
The safety of Triclosan during pregnancy is a subject of ongoing research and some clinical caution. While it is not strictly prohibited, studies have shown that Triclosan can cross the placenta and be detected in amniotic fluid. Some animal studies suggest it may interfere with hormones like estrogen and thyroid hormone, which are critical for fetal development. Because of these potential risks, some healthcare providers recommend that pregnant women avoid Triclosan-containing products if an effective alternative exists. If you are pregnant or planning to become pregnant, discuss your use of antimicrobial toothpastes with your obstetrician.
Triclosan begins to kill or inhibit bacteria almost immediately upon contact. In the context of dental health, clinical studies show that significant reductions in plaque and gingivitis are typically observed after 4 to 6 weeks of consistent, twice-daily use. For surgical sutures, the antimicrobial effect begins the moment the wound is closed and continues for several days during the critical initial healing phase. It is important to use the product consistently as directed to maintain its protective effects. If you do not see an improvement in your gum health after a month, consult your dentist.
Yes, you can stop using Triclosan-containing products at any time without experiencing withdrawal symptoms. There is no physical dependence associated with this antimicrobial agent. However, if you were using Triclosan toothpaste to manage a chronic condition like gingivitis, you may notice that your gum redness or bleeding returns once you stop. To prevent a recurrence of dental issues, it is important to replace Triclosan with another effective oral hygiene routine. Talk to your dentist about the best alternative for your specific needs before making a change.
If you miss a 'dose' of Triclosan, such as forgetting to brush your teeth with a specific toothpaste, simply brush as soon as you remember or wait until your next scheduled time. There is no need to use extra toothpaste or brush for a longer duration to compensate for the missed session. The effectiveness of Triclosan in oral care comes from regular, daily application rather than a single large dose. Consistency is the key to preventing bacterial buildup and maintaining healthy gums. Just resume your normal routine as soon as possible.
There is no clinical evidence to suggest that the topical or dental use of Triclosan causes weight gain in humans. While some researchers have investigated whether environmental chemicals (called 'obesogens') can affect metabolism, Triclosan has not been definitively linked to weight changes in clinical trials. Most Triclosan exposure is localized and the systemic absorption is very low. If you are experiencing unexpected weight gain, it is likely due to other factors such as diet, exercise, or underlying medical conditions. You should discuss any significant weight changes with your primary care physician.
Triclosan is generally safe to use alongside most systemic medications, such as blood pressure pills, diabetes medications, or antidepressants. Because it is used topically, it does not typically interfere with how other drugs are absorbed or metabolized in the body. However, you should be cautious when using other topical antimicrobial treatments on the same area of skin, as this can increase the risk of irritation. Always inform your healthcare provider about all the products you use, including over-the-counter items and dental products. This helps them ensure there are no unexpected interactions with your overall treatment plan.
Triclosan itself is a chemical ingredient rather than a brand-name drug, so it is found in many different products under various labels. While some famous brands like Colgate Total historically used Triclosan (and have since reformulated in many regions), you can find the ingredient in many 'store brand' or generic antibacterial toothpastes and medical supplies. When looking for a generic version, check the 'Active Ingredients' section of the Drug Facts label for the word 'Triclosan.' It is widely available and usually less expensive than major brand-name antimicrobial products.
Other drugs with the same active ingredient (Triclosan)
> Warning: Stop using any Triclosan-containing product and call your doctor immediately if you experience any of the following serious symptoms:
The long-term effects of Triclosan exposure are the subject of ongoing scientific debate and are the primary reason for recent regulatory restrictions. Potential long-term concerns include:
Unlike systemic prescription drugs, Triclosan is regulated primarily as an OTC drug or a component of medical devices. However, the FDA has issued strong statements regarding its removal from consumer soaps due to safety and efficacy concerns. It is important to distinguish between the 'ban' in soaps and its continued 'approval' in toothpaste and sutures.
Report any unusual symptoms or persistent irritation to your healthcare provider or dentist promptly. Monitoring for skin changes or oral mucosal health is recommended during long-term use.
Patients with known thyroid disorders or hormone-sensitive conditions should discuss the use of Triclosan-containing products with their endocrinologist. While the FDA currently maintains that Triclosan in toothpaste is safe, some patients prefer to avoid it out of an abundance of caution regarding potential interference with thyroid stimulating hormone (TSH) or estrogen levels.
Triclosan is highly persistent in the environment and is toxic to aquatic life. When you wash Triclosan-containing products down the drain, they can enter the water system, where they may contribute to environmental degradation and the development of resistant bacteria in the wild.
There are no standard laboratory monitoring requirements (like blood draws) for the general use of Triclosan-containing toothpaste or sutures. However, for patients using these products long-term, the following are recommended:
Triclosan does not have any known sedative or psychoactive effects. It does not impair the ability to drive or operate heavy machinery.
There are no known direct interactions between alcohol consumption and the topical or dental use of Triclosan. However, alcohol-based mouthwashes used in conjunction with Triclosan toothpaste may increase the risk of oral dryness or irritation in sensitive individuals.
There is no 'withdrawal syndrome' associated with stopping the use of Triclosan. However, if you are using it to manage a specific condition like gingivitis, stopping use may lead to a recurrence of gum inflammation and plaque buildup. If you wish to discontinue Triclosan, consult your dentist for an alternative antimicrobial or mechanical cleaning strategy.
> Important: Discuss all your medical conditions, especially thyroid issues and skin sensitivities, with your healthcare provider before starting or continuing a regimen that includes Triclosan.
The use of Triclosan toothpaste alongside prescription-strength antimicrobial mouthrinses (like Chlorhexidine) should be managed by a dentist. Using both simultaneously may be redundant and could lead to an excessive depletion of the natural oral flora, potentially predisposing the patient to oral candidiasis (thrush).
There are no known interactions between Triclosan and specific foods. Unlike some oral antibiotics, the efficacy of Triclosan in toothpaste is not affected by the consumption of dairy, caffeine, or high-fat meals. However, it is generally recommended to avoid eating or drinking for 30 minutes after using Triclosan toothpaste to ensure the 'substantivity' (sticking power) of the medication is not compromised.
There is limited data on interactions between Triclosan and herbal supplements. However, patients using supplements known to affect thyroid function (such as high-dose iodine or kelp) should be aware that Triclosan has also been studied for its potential thyroid-disrupting effects. The cumulative impact is unknown but warrants caution.
Triclosan does not typically interfere with standard blood chemistry or hematology panels. However, it can be detected in urine toxicology screens if specific tests for environmental phenols are conducted. It does not cause false positives on standard drug-of-abuse screens.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, even if you are only using Triclosan topically.
Triclosan should not be applied to large areas of broken, burned, or severely denuded skin. The damaged skin barrier can lead to significantly higher systemic absorption than occurs through intact skin, increasing the risk of systemic toxicity.
Patients who react to Triclocarban (another common antimicrobial) or Hexachlorophene may exhibit cross-sensitivity to Triclosan due to their similar chemical structures. If you have had a reaction to 'antibacterial' soaps in the past, you should exercise extreme caution when using Triclosan-containing toothpaste or medical devices.
> Important: Your healthcare provider will evaluate your complete medical history, including any past allergic reactions to soaps or cosmetics, before recommending products containing Triclosan.
Triclosan is approved for use in children aged 6 and older in the form of toothpaste. It is NOT approved for use in consumer soaps for children. The primary concern in the pediatric population is the potential for Triclosan to contribute to the 'Hygiene Hypothesis'—the idea that over-sanitizing a child's environment may lead to an increase in allergies and asthma. Furthermore, the risk of antibiotic resistance is a significant public health consideration for the next generation.
In elderly patients, the primary concern is skin integrity and polypharmacy. Older adults may have more permeable skin, leading to higher absorption of topically applied Triclosan. There is no evidence that Triclosan interacts with common geriatric medications like blood pressure or heart medicines, but the cumulative effect of using multiple antimicrobial products (soaps, lotions, toothpastes) should be monitored by a healthcare provider.
For patients with a Glomerular Filtration Rate (GFR) below 30 mL/min, the clearance of conjugated Triclosan metabolites may be reduced. While this is unlikely to cause acute toxicity from toothpaste use, patients with end-stage renal disease (ESRD) should be aware that systemic levels of the compound may remain elevated for longer periods compared to individuals with healthy kidney function.
Patients with Child-Pugh Class B or C hepatic impairment may have a reduced capacity for glucuronidation. Since this is the primary pathway for Triclosan detoxification, these patients may be at a slightly higher risk for systemic side effects if they use large amounts of Triclosan-containing products. However, no specific dose adjustments are currently mandated.
> Important: Special populations, particularly pregnant women and those with chronic organ failure, require an individualized medical assessment before using antimicrobial chemicals long-term.
| Parameter | Value |
|---|---|
| Bioavailability | ~5-10% (oral/dental); lower for intact skin |
| Protein Binding | ~94-98% (primarily to albumin) |
| Half-life | 13 - 29 hours |
| Tmax | 1 - 4 hours (following oral ingestion) |
| Metabolism | Hepatic (Glucuronidation and Sulfation) |
| Excretion | Renal (~70%), Fecal (~25%) |
Triclosan is classified as a bisphenol antiseptic and a FabI inhibitor. It is related to other phenolic antiseptics like hexachlorophene, though it is generally considered to have a more favorable safety profile for topical use in adults. Within the therapeutic area of dentistry, it is categorized as an antigingivitis/antiplaque agent.