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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Amosan Oral Wound Cleanser Mint
Generic Name
Sodium Perborate Monohydrate
Active Ingredient
Sodium PerborateCategory
Other
Salt Form
Monohydrate
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 1.2 g/1.7g | POWDER, FOR SOLUTION | ORAL | 71223-001 |
Detailed information about Amosan Oral Wound Cleanser Mint
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Amosan Oral Wound Cleanser Mint, you must consult a qualified healthcare professional.
Sodium Perborate is an inorganic peroxide used primarily as an oxidizing antiseptic in dental bleaching and as a preservative in ophthalmic solutions. It releases hydrogen peroxide upon contact with moisture to provide localized antimicrobial and whitening effects.
Dosage for Sodium Perborate depends entirely on the clinical application and the specific product formulation. Because it is an oxidizing agent, precise application is necessary to avoid tissue damage.
While topical or dental use does not usually require adjustment, patients with severe renal (kidney) impairment should use perborate-containing oral rinses with caution. If accidental ingestion occurs, these patients are at a much higher risk for systemic boron toxicity because the kidneys are the primary route of elimination.
No specific dosage adjustments are required for patients with liver disease, as Sodium Perborate is not metabolized by the liver.
Older adults may have thinner oral mucosa (lining of the mouth) and reduced salivary flow. They should be monitored for increased irritation when using perborate-based oral rinses.
Sodium Perborate is for LOCAL USE ONLY. It must never be swallowed.
If you miss a dose of an oral rinse, use it as soon as you remember, unless it is almost time for the next dose. Do not double the concentration or the frequency to catch up. For dental bleaching procedures, missing an appointment for the replacement of the internal paste can lead to over-bleaching or increased risk of tooth damage; contact your dentist immediately.
Systemic overdose (ingestion) of Sodium Perborate is a medical emergency. Boron toxicity (borism) can be fatal.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or extend the duration of treatment without medical guidance.
When used as intended for dental or oral care, common side effects are usually localized to the site of application:
> Warning: Stop using Sodium Perborate products and call your doctor or dentist immediately if you experience any of the following:
No FDA black box warnings currently exist for Sodium Perborate. However, it is strictly labeled for external/topical use only, with clear warnings regarding its toxicity if ingested. The primary safety concern is the risk of boron poisoning, particularly in pediatric populations.
Report any unusual symptoms or persistent irritation to your healthcare provider or dentist promptly. Monitoring the condition of the gingiva and the structural integrity of the tooth is a standard part of follow-up care during Sodium Perborate treatment.
Sodium Perborate is a potent chemical oxidizer. Its safety is highly dependent on proper application and the prevention of systemic ingestion. Patients must be aware that while it is effective for whitening and cleansing, it is not a benign substance. It should be kept out of the reach of children at all times, as even small amounts of the concentrated powder can be toxic to a toddler.
There are no FDA black box warnings for Sodium Perborate. It is generally recognized as safe (GRAS) for its intended OTC uses when used according to label instructions.
Sodium Perborate does not have any known sedative effects and is not expected to interfere with the ability to drive or operate heavy machinery. If using ophthalmic drops, your vision may be temporarily blurred for a few minutes after application; wait until your vision clears before driving.
There are no direct chemical interactions between Sodium Perborate and alcohol. However, alcohol can dry out the oral mucosa and increase the risk of irritation when using perborate-based oral rinses. It is generally advisable to avoid alcohol-containing mouthwashes or high alcohol consumption during treatment for oral ulcers.
Sodium Perborate treatment for oral hygiene should be discontinued after 7 days unless otherwise directed. There is no withdrawal syndrome associated with this medication. For dental bleaching, the treatment is discontinued once the desired aesthetic result is reached or if signs of tooth sensitivity become unmanageable.
> Important: Discuss all your medical conditions, especially any history of kidney disease or oral surgery, with your healthcare provider before starting Sodium Perborate.
Sodium Perborate should not be used simultaneously with other potent oxidizing agents or specific chemical catalysts.
There are no significant interactions between Sodium Perborate and specific foods, as the drug is not intended for systemic absorption. However, when using oral rinses:
For each interaction, the primary concern is either the neutralization of the perborate's oxidizing power (reducing efficacy) or an increase in tissue irritation (increasing toxicity). Management usually involves spacing the application of different products by several hours.
> Important: Tell your doctor or dentist about ALL medications, supplements, and herbal products you are taking, including those applied topically to the mouth or eyes.
Sodium Perborate must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis by a healthcare provider:
Patients who have experienced contact dermatitis or irritation from other boron-containing compounds (such as Borax or boric acid found in some detergents or pesticides) may exhibit cross-sensitivity to Sodium Perborate. Similarly, those sensitive to hydrogen peroxide may react poorly to the decomposition products of Sodium Perborate.
> Important: Your healthcare provider will evaluate your complete medical history, including any previous reactions to dental products, before prescribing or using Sodium Perborate.
Sodium Perborate is not formally categorized by the FDA's old letter-based pregnancy system, but boron (its metabolite) has been studied in animal models. High systemic doses of boron have been shown to cause developmental toxicity, including reduced fetal body weight and skeletal malformations in rats and rabbits.
In humans, the amount of boron absorbed from the occasional use of a Sodium Perborate oral rinse or a dental bleaching procedure is extremely low and unlikely to reach levels that would cause fetal harm. However, as a precaution, many dentists recommend delaying elective internal bleaching procedures until after pregnancy. If an oral rinse is required for an infection, it should be used for the shortest duration possible.
It is not known whether the metabolites of Sodium Perborate are excreted in human breast milk. Given that systemic absorption from topical dental use is minimal, the risk to a nursing infant is considered very low. However, breastfeeding mothers should avoid applying perborate-containing products to the breast area to prevent direct ingestion by the infant. Always consult a pediatrician before using any medication while breastfeeding.
Sodium Perborate is generally safe for use in older children and adolescents when supervised by a professional. The primary concern is the risk of ingestion. Children have a smaller body mass, making them much more susceptible to boron toxicity. A dose of boron that might only cause mild upset in an adult could be fatal to a small child. Products containing Sodium Perborate should be stored in child-resistant packaging.
Elderly patients may be more prone to oral mucosal irritation due to age-related thinning of the tissues. Furthermore, since renal function naturally declines with age, the clearance of any absorbed borate may be slower in older adults. No specific dosage adjustments are typically required for topical use, but the 7-day limit for oral rinses should be strictly enforced.
In patients with chronic kidney disease (CKD), the elimination half-life of boron is significantly prolonged. While the small amounts used in dental bleaching are unlikely to be problematic, these patients should avoid frequent use of perborate-containing OTC products. If systemic toxicity occurs, hemodialysis is the only effective way to clear the borate ion in patients with renal failure.
There are no known issues with the use of Sodium Perborate in patients with liver disease, as the compound is cleared through the kidneys and does not undergo hepatic metabolism. No dosage adjustments are necessary.
> Important: Special populations require individualized medical assessment. Always inform your specialist about your pregnancy status or any underlying organ dysfunction.
Sodium Perborate functions as a 'solid-state' reservoir of hydrogen peroxide. Its molecular structure consists of a peroxo-bridged dimer. When dissolved in water, the peroxo bonds break, releasing hydrogen peroxide ($H_2O_2$) and sodium metaborate ($NaBO_2$).
The therapeutic effect is achieved through the oxidative power of the released $H_2O_2$. In the presence of organic material or the enzyme catalase, $H_2O_2$ decomposes into water and a highly reactive nascent oxygen atom or hydroxyl radicals. These radicals oxidize the double bonds of organic pigments in teeth, converting them into colorless single bonds. In microbes, these radicals cause irreversible damage to the cell membrane and essential proteins, leading to rapid cell death.
| Parameter | Value |
|---|---|
| Bioavailability | Negligible (Topical); High (Oral Ingestion) |
| Protein Binding | 0% (Borate ion does not bind to plasma proteins) |
| Half-life | ~21 hours (Borate ion in healthy adults) |
| Tmax | 1–3 hours (Following oral ingestion) |
| Metabolism | Non-enzymatic hydrolysis to $H_2O_2$ and Borate |
| Excretion | Renal (90% as Boric Acid/Borate) |
| Distribution | Total body water; concentrates in bone |
Sodium Perborate is classified as an Oxidizing Antiseptic and a Dental Bleaching Agent. Within the therapeutic area of dentistry, it is grouped with other peroxides like carbamide peroxide and hydrogen peroxide, though it is unique due to its solid form and slower, more controlled release of oxygen.
Common questions about Amosan Oral Wound Cleanser Mint
Sodium Perborate is primarily used in dentistry for the 'walking bleach' technique to whiten teeth that have darkened after a root canal. It is also found in certain oral wound cleansers and mouthwashes to treat minor gum irritations and canker sores. Additionally, it serves as a 'disappearing' preservative in some brands of artificial tears, where it breaks down into harmless water and oxygen upon contact with the eye. Because it is a stable powder that releases hydrogen peroxide slowly, it is preferred for procedures requiring long-term contact with tissues. It is not used for systemic infections and must never be swallowed. Always use it under the guidance of a dental or medical professional.
The most common side effects are localized irritation at the site of application, such as redness or a stinging sensation in the gums. When used for tooth bleaching, temporary tooth sensitivity to hot or cold is frequently reported. Some users of oral rinses may notice a white, filmy layer on the inside of their cheeks, which is a sign of mild tissue irritation. If the product is used in the eyes as a preservative, mild redness or a brief stinging feeling may occur. These effects are usually temporary and resolve once the treatment is stopped. If you experience severe pain or ulceration, you should contact your dentist or doctor immediately.
There is no direct chemical interaction between alcohol and Sodium Perborate that would cause a dangerous reaction. However, alcohol is known to be a drying agent and can irritate the sensitive lining of the mouth. If you are using Sodium Perborate to treat oral ulcers or gum inflammation, drinking alcohol may slow the healing process and increase the burning sensation caused by the medication. It is generally recommended to avoid alcohol-based mouthwashes and limit alcoholic beverages during the course of treatment to allow the oral tissues to heal. Always follow the specific advice provided by your healthcare provider regarding lifestyle choices during treatment.
The safety of Sodium Perborate during pregnancy has not been extensively studied in humans. Animal studies have shown that high doses of its metabolite, boron, can cause developmental issues in the fetus. While the amount of boron absorbed from a dental procedure or a 7-day course of oral rinse is very small, most dental professionals recommend postponing elective whitening procedures until after pregnancy as a precaution. If a Sodium Perborate rinse is medically necessary to treat an infection, it should be used only under the supervision of a doctor. Always inform your dentist or physician if you are pregnant or planning to become pregnant before starting any new treatment.
The timeframe for Sodium Perborate to show results depends on the condition being treated. For oral wound cleansing and minor gum infections, you may feel relief from symptoms within 24 to 48 hours of starting the rinse. For internal tooth bleaching, the process is much slower; it typically takes 3 to 7 days for the oxygen to penetrate the tooth and break down stains. Often, the dentist must replace the bleaching paste 2 or 3 times over several weeks to achieve the desired level of whiteness. If you do not see improvement in oral sores after 7 days of use, you should consult your healthcare provider for further evaluation.
Yes, you can stop using Sodium Perborate products suddenly, as there are no withdrawal symptoms associated with this chemical. In fact, oral rinses containing Sodium Perborate are only intended for short-term use (up to 7 days). Using the product longer than recommended can lead to complications like boron accumulation or changes in the natural balance of bacteria in your mouth. If you are undergoing a professional bleaching treatment and wish to stop, you must visit your dentist to have the paste removed and the tooth properly sealed. Leaving the bleaching material in the tooth indefinitely can lead to structural damage or root resorption.
If you miss a dose of an oral rinse, use it as soon as you remember, but if it is nearly time for your next scheduled dose, skip the missed one and return to your regular routine. Do not use extra solution or rinse more frequently to make up for a missed dose. For internal dental bleaching, missing your follow-up appointment to replace or remove the paste is more serious. The bleaching agent can become less effective over time or, conversely, may cause over-bleaching if left too long. If you cannot make your scheduled dental appointment, call your dentist's office to reschedule as soon as possible to ensure the safety of your tooth.
No, Sodium Perborate does not cause weight gain. It is used topically or locally and is not absorbed into the bloodstream in amounts that would affect your metabolism, appetite, or fat storage. It does not contain calories, nor does it interfere with hormones related to weight regulation. If you notice unexpected weight changes while using a product containing Sodium Perborate, it is likely due to another underlying medical condition or medication. You should discuss any significant changes in your weight with your primary care physician to determine the cause, as this is not a known side effect of Sodium Perborate.
Sodium Perborate is generally safe to use alongside most systemic medications (pills taken by mouth), but it can interact with other topical products. For example, it should not be used at the same time as other oral antiseptics or certain enzymatic wound cleansers, as the oxidizing action of the perborate can deactivate them. If you are using medicated eye drops and an artificial tear that contains a perborate preservative, you should wait at least 5 to 10 minutes between the two products to prevent interference. Always provide your doctor or dentist with a full list of all medications, including over-the-counter drugs and herbal supplements, to ensure there are no specific concerns.
Sodium Perborate is a chemical ingredient rather than a brand-name drug, so it is available in various generic formulations. You can find it as an active ingredient in generic 'Oral Debriding Agents' or 'Oxygenating Rinses.' In the past, it was the primary ingredient in the brand Amosan, which is now often sold under store-brand labels with the same concentration. In dentistry, it is purchased as a bulk chemical for professional use. Because it is an older, well-established compound, generic versions are typically very affordable. When purchasing over-the-counter, always check the active ingredients list on the 'Drug Facts' label to confirm the presence of Sodium Perborate.
Other drugs with the same active ingredient (Sodium Perborate)