Cleanstar Clove

Approved and Clinically Accepted Uses:

• Dental Applications:
• Temporary relief of toothache and dental pain
• Topical analgesic and antiseptic for oral mucosa irritation
• Adjunctive use in managing denture stomatitis and oral ulcers
• Antimicrobial Uses:
• Topical antiseptic for minor wounds, cuts, and skin infections
• Relief from fungal infections such as athlete’s foot and ringworm (adjunctive use)
• Gastrointestinal Uses:
• Relief of flatulence and digestive discomfort
• Used as a carminative and spasmolytic agent in traditional medicine
• Respiratory Conditions (Traditional Use):
• Symptomatic relief of cough, bronchitis, and cold-related congestion
• Other Uses (Traditional and Complementary Medicine):
• Insect repellent
• Aromatherapy for stress relief and analgesia

Note: Clove oil is widely used in traditional, complementary, and alternative medicine. Its use as a pharmaceutical agent is primarily topical and symptomatic; it is not approved for systemic therapeutic indications in most regulatory jurisdictions.

• Topical Use (Dental Pain):
• Apply 1–2 drops of diluted clove oil on a cotton pellet and place near the affected tooth. Do not swallow.
• Repeat every 2–3 hours as needed for temporary relief.
• Topical Use (Skin Application):
• Dilute 1–5% clove oil in a carrier oil (e.g., coconut, olive oil) before applying to skin.
• Apply 2–3 times daily to affected area.
• Inhalation (Aromatherapy):
• Add 2–3 drops to diffuser or steam inhalation.
• Oral Use:
• Internal use is generally not recommended without medical supervision due to risk of toxicity.
• When used traditionally as a digestive aid, doses vary widely (usually <0.1 mL essential oil diluted in water or food).
• Pediatrics and Special Populations:
• Use with caution in children; avoid use in infants.
• Elderly and pregnant or breastfeeding women should avoid systemic use due to limited safety data.
• Administration Routes:
• Topical (oral mucosa or skin)
• Inhalational (aromatherapy)
• Avoid undiluted use on mucous membranes or skin to prevent irritation or burns.

Clove oil’s primary active component, eugenol, exerts analgesic, antiseptic, anti-inflammatory, and antimicrobial effects. Eugenol inhibits prostaglandin synthesis by blocking cyclooxygenase (COX) enzymes, thereby reducing pain and inflammation. It also disrupts microbial cell membranes leading to antifungal and antibacterial activity. Its local anesthetic effect results from the reversible blockade of nerve conduction by interacting with neuronal ion channels. Additionally, eugenol exhibits antioxidant properties by scavenging free radicals, contributing to tissue protection.

• Absorption: When applied topically or used orally in diluted forms, eugenol is absorbed through mucous membranes and skin.
• Distribution: Distributes rapidly due to lipophilicity; crosses biological membranes easily.
• Metabolism: Primarily metabolized in the liver via conjugation pathways (glucuronidation and sulfation).
• Elimination: Metabolites are excreted mainly via urine.
• Onset of Action: Topical analgesic effects observed within minutes of application.
• Half-life: Eugenol elimination half-life is approximately 3–6 hours after systemic absorption.

• Pregnancy: There is insufficient clinical data on safety during pregnancy. Animal studies suggest caution due to possible uterine stimulant effects of eugenol. Therefore, clove oil use during pregnancy is generally not recommended unless prescribed by a healthcare professional.
• Lactation: Safety during breastfeeding is not established. Use is not recommended due to potential toxicity and lack of data.

• Primary Class: Herbal/Phytotherapeutic Agent
• Subclass: Essential Oil with Analgesic, Antimicrobial, and Anti-inflammatory Properties

• Known hypersensitivity or allergy to clove oil or eugenol
• Use on broken or irritated skin without dilution
• Avoid use in neonates and infants
• Severe hepatic or renal impairment (systemic exposure risks)

• Avoid undiluted application to skin or mucous membranes to prevent chemical burns and irritation.
• High doses or prolonged use may cause systemic toxicity, including hepatotoxicity and neurotoxicity.
• Risk of allergic contact dermatitis exists, especially with repeated exposure.
• Use with caution in patients with bleeding disorders or on anticoagulants as eugenol may have antiplatelet effects.
• Stop use immediately if signs of hypersensitivity (rash, swelling, difficulty breathing) occur.

Common:

• Local irritation, redness, or burning sensation at application site
• Allergic contact dermatitis with prolonged or repeated use

Serious (Rare):

• Chemical burns if used undiluted on mucous membranes or skin
• Systemic toxicity with overdose: nausea, vomiting, dizziness, convulsions, liver damage

Severity: Usually mild and reversible with discontinuation; severe reactions are rare and dose-dependent.

• May potentiate effects of anticoagulant or antiplatelet drugs, increasing bleeding risk.
• Potential interaction with other hepatically metabolized drugs due to liver enzyme effects, though data are limited.
• No known significant food or alcohol interactions documented.

• No major changes in approved uses; traditional topical and dental analgesic uses remain the mainstay.
• Increased caution advised regarding unregulated systemic ingestion due to toxicity reports.
• Current clinical guidelines recommend clove oil as a complementary option for short-term topical dental pain relief, not as a replacement for dental treatment.

• Store in a tightly sealed container away from light, heat, and moisture.
• Optimal temperature: 15°C to 30°C (59°F to 86°F)
• Keep out of reach of children and pets.
• Protect from freezing.
• Use amber-colored bottles to prevent light-induced degradation.