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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Clove,zanthoxylum Bungeanum Fruit,cynomorium Coccineum Subsp.songaricum Whole,cnidium Monnieri Whole
Brand Name
Extended Topical Sprays For Men
Generic Name
Clove,zanthoxylum Bungeanum Fruit,cynomorium Coccineum Subsp.songaricum Whole,cnidium Monnieri Whole
Active Ingredient
CloveCategory
Standardized Insect Venom Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 2.8 g/100mL | LIQUID | TOPICAL | 84260-010 |
Detailed information about Extended Topical Sprays For Men
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Extended Topical Sprays For Men, you must consult a qualified healthcare professional.
Clove (Syzygium aromaticum) is utilized in clinical settings as a non-standardized plant allergenic extract for diagnostic testing and as a topical analgesic in dental medicine. It belongs to the class of non-standardized plant allergenic extracts used for hypersensitivity assessment.
Dosage for Clove varies significantly based on the intended clinical use. Patients must follow the specific instructions provided by their healthcare professional.
For the temporary relief of a toothache, a small amount of clove oil (1 to 2 drops) is typically applied to a sterile cotton pellet. This pellet is then placed gently into the cavity of the affected tooth or against the surrounding gum tissue. This may be repeated every 2 to 3 hours as needed, but should not exceed 4 applications per day without consulting a dentist.
In diagnostic settings, the dosage is standardized by the manufacturer of the allergenic extract. For skin prick testing, a single drop of the extract (often a 1:10 or 1:20 w/v dilution) is applied to the skin, followed by a light puncture. For intradermal testing, a much smaller volume (0.02 mL) of a more dilute solution is injected into the dermis.
Clove should be used with extreme caution in the pediatric population.
While systemic absorption from topical use is low, patients with severe renal impairment (Stage 4 or 5 Chronic Kidney Disease) should use Clove products cautiously, as the kidneys are responsible for excreting eugenol metabolites. No specific dose adjustment is standardized, but frequency of use should be minimized.
Because eugenol is metabolized via hepatic glucuronidation, patients with significant liver disease (e.g., cirrhosis) may have a reduced capacity to clear the drug. These patients are at a higher risk for eugenol-induced hepatotoxicity if the product is ingested or used excessively.
Geriatric patients often have thinner oral mucosa and may be more susceptible to the localized irritating effects of Clove. Additionally, age-related declines in renal function should be considered if Clove is used over large areas or for extended periods.
Clove products are intended for topical or diagnostic use only. They should never be injected systemically (except for controlled intradermal testing) or ingested in large quantities.
Since Clove is typically used on an 'as-needed' basis for pain or as a one-time diagnostic test, missed doses are rarely a clinical concern. If you are using it on a schedule recommended by your dentist and miss a dose, apply it as soon as you remember. If it is almost time for the next application, skip the missed dose. Do not apply double the amount to make up for a missed dose.
An overdose of Clove oil (eugenol) is a medical emergency, particularly in children. Signs of systemic eugenol toxicity include:
In the event of accidental ingestion or excessive topical application leading to systemic symptoms, contact a Poison Control Center or seek emergency medical attention immediately.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
When applied topically, Clove frequently causes localized reactions. These are generally mild but can be uncomfortable:
While rare, systemic reactions to Clove can be life-threatening. Stop using the product and seek emergency care if you experience:
> Warning: Stop taking Clove and call your doctor immediately if you experience any of these.
Clove is not intended for long-term use. Chronic application to dental tissues can lead to:
No FDA black box warnings currently exist for Clove as a Non-Standardized Plant Allergenic Extract or as a topical dental analgesic. However, its use is governed by strict safety guidelines regarding ingestion and pediatric safety.
Report any unusual symptoms to your healthcare provider. You may also report side effects to the FDA at 1-800-FDA-1088.
Clove and its primary component, eugenol, are potent chemical agents. While safe for their intended diagnostic and localized uses, they pose significant risks if misused. Patients must be aware that 'natural' does not mean 'harmless.' Clove oil is a concentrated essential oil that can be caustic to mucous membranes and toxic if absorbed systemically in large quantities.
No FDA black box warnings for Clove.
For standard topical dental use or a one-time allergy test, routine lab monitoring is not required. However, if a patient is suspected of eugenol poisoning or has used the product excessively, the following may be monitored:
Clove does not typically cause sedation or cognitive impairment when used correctly. However, if a systemic allergic reaction occurs, or if accidental ingestion leads to dizziness, patients should avoid driving or operating heavy machinery until symptoms have completely resolved.
Patients should avoid consuming alcohol while using Clove for dental pain. Alcohol can irritate the oral mucosa further and may theoretically increase the risk of liver strain if significant amounts of eugenol are absorbed.
Clove should be discontinued as soon as the dental pain is addressed by a professional or the allergy test is completed. There is no withdrawal syndrome associated with Clove, but stopping use is essential to prevent tissue damage and sensitization.
> Important: Discuss all your medical conditions with your healthcare provider before starting Clove.
There are no drugs that are strictly contraindicated for use with topical Clove, but the following should be avoided if Clove is ingested:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Clove must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis by a physician:
Patients allergic to Balsam of Peru often show cross-sensitivity to Clove because both contain eugenol and related cinnamic acid derivatives. If you have a known allergy to perfumes or certain flavorings, you may be at higher risk for a reaction to Clove.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Clove.
Clove is classified as FDA Pregnancy Category C (or equivalent). There are no adequate and well-controlled studies of Clove extracts in pregnant women. Animal studies have shown that eugenol can cross the placental barrier. While occasional topical use for a toothache is generally considered low-risk, high-dose or systemic exposure should be avoided. It is unknown if Clove can cause fetal harm or affect reproductive capacity.
It is not known whether the components of Clove are excreted in human milk. Because many drugs are excreted in milk and the potential for serious adverse reactions in nursing infants exists, caution should be exercised. If Clove oil is applied to the breast or chest area, it must be thoroughly cleaned before breastfeeding to prevent the infant from ingesting the oil.
As discussed, Clove is not recommended for infants and very young children. In older children, it should only be used under strict medical or parental supervision for short-term dental pain. Pediatric patients are more susceptible to the toxic effects of eugenol, including seizures and liver failure, even at relatively low doses.
Clinical studies of Clove extracts have not included sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
In patients with impaired renal function, the water-soluble glucuronide conjugates of eugenol may accumulate. While these metabolites are generally less toxic than the parent compound, the long-term effects of such accumulation are not well-studied. Use with caution in patients with a GFR < 30 mL/min.
The liver is the primary organ for detoxifying eugenol. Patients with Child-Pugh Class B or C hepatic impairment should avoid systemic exposure to Clove. Even topical use should be limited to prevent any potential for systemic 'spillover' that the liver cannot process.
> Important: Special populations require individualized medical assessment.
Clove's primary pharmacological agent, eugenol, works through several distinct pathways:
| Parameter | Value |
|---|---|
| Bioavailability | High (Oral/Mucosal) |
| Protein Binding | ~80-90% (Albumin) |
| Half-life | 1 - 4 hours |
| Tmax | 0.5 - 2 hours |
| Metabolism | Hepatic (Glucuronidation/Sulfation) |
| Excretion | Renal (>95%) |
Clove is classified as a Non-Standardized Plant Allergenic Extract [EPC]. It is related to other botanical extracts used in immunology, such as those derived from cinnamon, vanilla, or balsam, which share similar aromatic and allergenic constituents.
Common questions about Extended Topical Sprays For Men
Clove is primarily used in clinical medicine as a diagnostic tool for allergy testing and as a topical analgesic for dental pain. As a 'Non-Standardized Plant Allergenic Extract,' it helps immunologists identify if a patient has a specific allergy to the plant. In dentistry, the active component eugenol provides temporary relief from toothaches by numbing the affected area. It is also used in some temporary dental fillings and cements due to its antiseptic properties. Always consult a healthcare professional before using clove for medical purposes.
The most common side effects of Clove when applied to the mouth include a sharp burning or stinging sensation, redness of the gums, and a strong, lingering taste. Some people may also experience mild swelling or a temporary loss of sensation in the tongue or cheeks if the oil spreads. These effects are usually localized and disappear shortly after the product is removed. However, if these symptoms persist or worsen, you should contact your dentist or doctor. It is important to apply the oil precisely to avoid irritating healthy tissue.
It is generally advised to avoid alcohol while using Clove for dental pain. Alcohol can further irritate the sensitive mucous membranes in the mouth and may interfere with the numbing effect of the clove oil. Additionally, because both alcohol and the active components of clove are processed by the liver, combining them could theoretically increase the metabolic strain on the liver. If you are using Clove as part of a diagnostic allergy test, alcohol should be avoided to ensure the skin's reaction is not masked or altered. Always follow the specific safety advice provided by your healthcare provider.
Clove is classified by the FDA as Category C, meaning there is not enough clinical data to confirm its safety during pregnancy. While small amounts used topically for a toothache are likely low-risk, the systemic absorption of eugenol could potentially affect the developing fetus. Pregnant women should consult their obstetrician before using any clove-based products. It is especially important to avoid ingesting clove oil or using it in high concentrations during pregnancy. Your doctor will help you weigh the benefits of pain relief against any potential risks to the baby.
When used for dental pain, Clove oil typically begins to work very quickly, often providing a numbing sensation within 30 to 90 seconds of application. The maximum effect is usually reached within a few minutes. However, this relief is temporary and generally lasts for only 1 to 3 hours. It is intended as a 'stop-gap' measure until you can see a dentist for a permanent solution. If you do not feel relief within 10 minutes, do not apply excessive amounts; instead, seek professional dental advice.
Yes, you can stop using Clove suddenly without any risk of withdrawal or physical dependence. Clove is not an addictive substance and is typically used only on an 'as-needed' basis for acute symptoms or as a one-time diagnostic test. Once your dental pain has been treated by a professional or your allergy test is complete, you should stop using the product. In fact, long-term use is discouraged because it can lead to tissue damage or the development of a permanent allergy. There is no need to taper the dose.
Because Clove is usually used only when needed for pain, missing a dose is not a significant concern. If you were instructed to use it on a specific schedule and you miss a time, apply it as soon as you remember. However, if it is almost time for your next scheduled application, skip the missed one and continue with your regular timing. Never apply a double dose to make up for one you missed, as this increases the risk of irritating your gums or experiencing toxic side effects. If you are unsure, contact your healthcare provider.
There is no clinical evidence to suggest that Clove, when used topically or for diagnostic purposes, causes weight gain. The active components like eugenol are used in very small quantities and are not known to affect metabolism, appetite, or fat storage in a way that would lead to weight changes. If you experience unexpected weight gain while using any medication, it is important to discuss this with your doctor to identify the underlying cause. Clove's primary effects are localized to the site of application and the immune system's response during testing.
Clove can interact with several types of medications, particularly those that affect blood clotting. Because clove oil has antiplatelet effects, taking it with blood thinners like Warfarin, Aspirin, or Clopidogrel can increase your risk of bleeding and bruising. It may also interact with medications for diabetes, potentially causing blood sugar levels to drop too low. Always provide your healthcare provider with a full list of all prescriptions, over-the-counter drugs, and herbal supplements you are taking. This allows them to check for potential interactions before you start using Clove.
Clove oil and eugenol are widely available as generic products and are often sold over-the-counter in pharmacies and health food stores. In the clinical setting, 'Non-Standardized Plant Allergenic Extracts' of Clove are produced by various specialized laboratories for use by allergists. There is no single 'brand name' for Clove, as it is a natural botanical substance. However, different manufacturers may have their own formulations or concentrations. When buying clove oil for dental pain, ensure you are purchasing a product labeled for medicinal use rather than aromatherapy.
Other drugs with the same active ingredient (Clove)