Description

Topical Oral Anesthetic Solution for Mucosal Numbing and Procedural Comfort

Product Overview

DYCLONINE HCl 0.5% Solution is a clear, aqueous, alcohol-free mucosal anesthetic designed to provide rapid and effective topical anesthesia for oropharyngeal and mucous membrane applications. With its unique non-caine chemical structure, Dyclonine Hydrochloride offers a safer alternative for patients with sensitivities to traditional amide and ester anesthetics, such as lidocaine or benzocaine. This 0.5% formulation delivers reliable numbing without systemic toxicity, irritation, or allergic risk, making it an ideal agent for use across dental, ENT, and procedural specialties.

Packaged in a generous 480 mL bottle, the solution is designed for easy dispensing in clinical and outpatient settings, ensuring both practitioner convenience and optimal patient throughput.

Clinical Applications

DYCLONINE HCl 0.5% is commonly used for:

• Pre-procedural oral rinsing before dental procedures (impressions, restorations, hygiene)

• Laryngoscopy, bronchoscopy, or endoscopy to suppress gag reflex and improve scope tolerance

• Intubation or airway manipulation as part of conscious sedation or general anesthesia prep

• Pain relief for oral ulcers, sore throats, mucositis, or aphthous lesions

• ENT procedures requiring local mucosal anesthesia without systemic agents

Its broad utility spans dentistry, otolaryngology (ENT), anesthesiology, speech therapy, and emergency care where rapid onset mucosal anesthesia is essential.

Pharmacological Profile

• Active Ingredient: Dyclonine Hydrochloride 0.5% w/v

• Mechanism of Action: Dyclonine is a topical anesthetic that inhibits voltage-gated sodium channels on sensory neurons, reducing neuronal excitability and preventing the initiation and propagation of pain signals.

• Onset: Within 1–2 minutes of application

• Duration: Approximately 30–45 minutes of localized anesthesia

• Metabolism: Local tissue degradation, minimal systemic absorption

• pH Range: Buffered for mucosal tolerability and stability

Unlike conventional caine-based anesthetics, dyclonine’s unique structure results in low cross-reactivity, making it highly suitable for patients with caine allergies or those requiring frequent mucosal anesthesia.

Formulation & Safety

• Alcohol-Free: Reduces mucosal drying and irritation

• Sugar-Free: Safe for diabetic patients and long-term oral use

• Non-Systemic: Minimal absorption, no CNS or cardiovascular depression

• Preservative-Free: Low risk of hypersensitivity reactions

• Clear Aqueous Solution: Easy to measure, rinse, and dispense

This solution is manufactured under stringent cGMP conditions with pharmaceutical-grade Dyclonine HCl to ensure purity, consistency, and patient safety. Its neutral pH and isotonic formulation promote excellent tolerability on sensitive or inflamed mucosa.

Directions for Use

• Rinse-and-spit method:
  Instruct patient to swish 5–10 mL of solution in the mouth for 30 seconds to 1 minute, then expectorate.
  Suitable before impressions, restorations, scaling, or procedures involving the oropharynx.

• Topical application:
  Apply via soaked cotton-tipped applicator directly onto affected mucosal site or lesion.
  May be used for aphthous ulcers, sore throat, or local trauma.

• Nebulized use (off-label):
  For procedural airway prep, under controlled professional settings.

Note: Avoid swallowing the solution. Do not exceed recommended volume without medical supervision.

Indications

• Oral and pharyngeal anesthesia for diagnostic or therapeutic procedures

• Reduction of gag reflex during dental or medical interventions

• Local pain relief for aphthous stomatitis, sore throat, mucositis, or denture irritation

• Short-term relief in procedures where conventional anesthetics are contraindicated

Contraindications & Precautions

• Known hypersensitivity to dyclonine or other local anesthetics

• Avoid in patients with impaired swallowing unless supervised

• Not intended for ophthalmic or injectable use

• Pediatric use should be under physician guidance

Although systemic toxicity is rare, prolonged or excessive use may result in numbness of the tongue or throat affecting swallowing reflex. Patients should avoid eating or drinking until full sensation returns.

Packaging

• Net Volume: 480 mL

• Container Type: Amber pharmaceutical-grade plastic bottle with tamper-evident seal

• Shelf Life: 12 months from compounding date when stored below 25°C (77°F)

• Storage: Store in a cool, dry place. Keep tightly closed and out of direct light. Shake gently before use if settled.

Why Choose Dyclonine HCl 0.5%?

• Non-caine alternative – ideal for allergy-prone patients

• Fast, effective onset with a clean, non-irritating feel

• Clear formulation for precise mucosal application

• Suitable for frequent use without systemic side effects

• Backed by long-standing use in dental and ENT clinical practice

DYCLONINE HCl 0.5% Solution combines safety, reliability, and broad clinical versatility into one powerful mucosal anesthetic. For healthcare providers seeking a non-caine, rapid-acting solution to manage pain and procedural sensitivity, this formulation is a trusted and proven choice.