Acerumen ear spray 40 ml

Important Disclaimer: This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product’s internal leaflet or consult a healthcare professional before use.

Drug Name: Acerumen Ear Spray 40 ml

Manufacturer:

Acerumen Ear Spray is manufactured by Laboratoires Gilbert, France — a reputable pharmaceutical company specializing in ENT and hygiene products, especially ear and nasal care. [1, 2]

Introduction:

Acerumen Ear Spray is an over-the-counter ear hygiene solution formulated to gently and effectively dissolve and eliminate excess earwax (cerumen). [1, 3] It is particularly useful for preventing earwax buildup and aiding in the removal of existing plugs without the need for mechanical intervention like syringing. Its unique spray format ensures easy, hygienic, and safe application, as it disperses the product through the sides rather than in a direct jet, which could potentially damage the eardrum. [1, 4]

Indications and Usage:

Acerumen is indicated for: [1, 3, 5]

• Routine Ear Hygiene: To maintain clean and healthy ears and prevent wax accumulation. [1, 3]
• Dissolving Earwax Plugs: To soften and facilitate the removal of existing cerumen blockages. [1, 3]
• Preventing Earwax Build-up: Especially useful for individuals who frequently use hearing aids, headphones, or earplugs, or those exposed to dusty environments. [1, 3]
• Preparation before Ear Irrigation: Can be used to soften earwax prior to professional ear syringing or other ENT procedures. [5]
• Safe use in adults and children from 6 months of age for both preventive and therapeutic ear care. [1, 3]

Characteristics:

Acerumen Ear Spray is a 2-in-1 solution that works by moistening and dissolving earwax. [1, 3] Its formulation is based on mild surfactants of plant origin (such as Sodium Acylsarcosinate and Sucrose Ester), which help to disperse fatty substances and reduce surface tension, making earwax easier to remove. [1, 3, 6] It is a non-foaming, non-greasy formula, pH balanced, dermatologically tested, and does not contain preservatives or gas propellants. [1, 3, 5]

• Form: Topical ear spray (liquid solution). [1, 3]
• Volume: 40 ml per bottle with a spray nozzle, providing approximately 270 doses. [1, 3]
• Active Ingredients: Mild surfactants (Sodium Acylsarcosinate and Sucrose Ester). [1, 3, 6]
• Formula: Plant-derived, preservative-free, non-greasy, pH balanced, dermatologically tested. [1, 3, 5]
• Action: Dissolves existing earwax plugs and prevents their formation. [1, 3]

Dosage and Administration:

Acerumen Ear Spray is for external otic use only. [1, 3]

• For Routine Ear Hygiene and Prevention: Spray twice into each ear, 2 times per week. [1, 3]
• For Existing Earwax Plugs (Treatment): Spray twice into the affected ear, morning and evening, for 3 to 4 consecutive days. [1, 3]
• Application Method:
  1. Tilt the head to the side not being treated (affected ear facing upwards). [1, 3]
  2. Insert the spray nozzle gently into the ear canal. [1, 3]
  3. Administer the spray (2 doses). [1, 3]
  4. Massage the base of the ear for about 1 minute. [1, 3]
  5. Return to an upright position and wipe away any excess product that may drip from the ear with a clean tissue. [1, 3]
  6. No rinsing is required. [1, 3]
• Age Suitability: Suitable for adults and children from 6 months of age. [1, 3]

Contraindications:

Do not use Acerumen Ear Spray in the following cases: [1, 3, 5]

• Known hypersensitivity to any component of the formula. [1, 3]
• Perforation of the eardrum. [1, 3]
• Active ear infection (otitis) or inflammation. [1, 3]
• Presence of tympanostomy tubes (grommets) or if you have had recent ear surgery. [1, 3]
• Children under 6 months of age (unless specifically advised by a physician). [1, 3]

Warnings and Precautions:

• For external use only – do not ingest or apply to eyes. In case of contact with eyes, rinse thoroughly with water. [1, 3, 5]
• Do not insert the nozzle too deeply into the ear canal, as this may cause irritation or damage. [1, 3, 5]
• If ear pain, discharge, dizziness, or any severe irritation occurs, discontinue use and consult a doctor immediately. [1, 3, 5]
• Keep out of reach of children. [1, 3, 5]
• Use within 3 months of opening. [1, 3]
• After each use, remove the nozzle and wash it with warm water to maintain hygiene. [1, 3]
• Do not share the spray bottle between individuals to prevent cross-contamination. [5]

Pharmacokinetics / Absorption:

As a topical ear solution, Acerumen acts locally within the external auditory canal to moisten and dissolve earwax, facilitating its natural elimination. [1, 3] Systemic absorption is negligible, and therefore, significant pharmacokinetic interactions are not expected. [1, 3]

Side Effects:

Acerumen is generally well-tolerated. Reported side effects are usually mild and temporary: [1, 3]

• Mild local irritation or tingling. [1, 3]
• Temporary feeling of ear fullness or warmth. [1, 3]
• Allergic skin reactions (extremely rare). [1, 3]

If any severe or persistent irritation occurs, discontinue use and consult a healthcare professional. [1, 3]

Drug Interactions:

No known systemic drug interactions are expected with Acerumen Ear Spray due to its local action and minimal systemic absorption. [1, 3] However, it is generally advised not to use concurrently with other otologic (ear) medications unless advised by a healthcare professional. Ensure the ear is properly cleaned before using medicated ear drops afterward. [5]

Patient Counseling:

• Always follow the instructions for use provided on the packaging or by your healthcare professional. [1, 3]
• Use only as directed — do not overuse. [1, 3]
• Do not use if you have a perforated eardrum, active ear infection, or ear tubes. [1, 3, 5]
• If symptoms persist or worsen, or if you experience ear pain, consult a doctor. [1, 3, 5]
• Store at room temperature (below 25°C), away from direct heat or sunlight, and out of reach of children. [1, 3, 5] Do not refrigerate. [1, 3]
• Discard the product 3 months after opening. [1, 3]
• Ensure nozzle hygiene by washing it with warm water after each use. [1, 3]

Sources:

• Laboratoires Gilbert Official Website - Acerumen: https://www.laboratoires-gilbert.com/en/products/acerumen/ [1]
• Laboratoires Gilbert - About Us: https://www.laboratoires-gilbert.com/en/about-us/ [2]
• Acerumen Product Information (various pharmacy/medical sites confirming details like age, usage, ingredients): https://www.pharmacie-citypharma.fr/en/acerumen-ear-spray-40ml-gilbert.html [3]
• Acerumen Ear Spray - Instructions for Use / Patient Leaflet (example from a reliable source): https://www.e-pharm.gr/en/acerumen-ear-spray-40ml [4]
• General Information on Earwax Removal Sprays (from a reputable medical/pharmaceutical source): https://www.nhs.uk/conditions/earwax/treatment/ [5]
• Wikipedia - Surfactants (for general info on mechanism): https://en.wikipedia.org/wiki/Surfactant [6]