Mastodon

Dettol Benzalkonium chloride (Spray) Instructions for Use

ATC Code

D08AJ01 (Benzalkonium)

Active Substance

Benzalkonium chloride (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with antibacterial action for external use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Antiseptic agent. It is a quaternary ammonium compound and belongs to cationic surfactants.

It has antimicrobial and antiviral activity against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex type 2, Staphylococcus aureus, has low activity against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum. It is not active against Mycoplasma spp.

Pharmacokinetics

When applied externally, it is practically not absorbed.

Indications

Apply the spray for antiseptic treatment of the skin, mucous membranes, and wounds to prevent infection and for cleansing.

Use for the management of seborrheic dermatitis to reduce microbial load on affected skin areas.

  • Antiseptic treatment of skin, mucous membranes, and wounds.
  • Seborrheic dermatitis.

ICD codes

ICD-10 code Indication
L21 Seborrheic dermatitis
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.1 Open wound of unspecified body region
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
ICD-11 code Indication
EA81.Z Seborrheic dermatitis, unspecified
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
ND56.0 Superficial injury of unspecified body region
ND56.1 Open wound of unspecified body region
QB9A Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Determine the dosage regimen individually based on the specific indication, the extent of the area requiring treatment, and the clinical response.

For the spray formulation, apply a sufficient amount to cover the affected area; the frequency of application is typically one to three times daily or as directed by a physician.

Adverse Reactions

Adverse reactions are generally localized to the site of application. Possible reactions include local skin irritation, such as redness, itching, or a burning sensation.

Allergic contact dermatitis and other hypersensitivity reactions may occur in susceptible individuals. Discontinue use if signs of a severe reaction appear.

Drug Interactions

Avoid concurrent use with anionic surfactants and soaps, as they can inactivate the cationic benzalkonium chloride, significantly reducing its antimicrobial efficacy.

Do not mix with iodine or nitrates, as chemical incompatibility may occur. The activity of this agent may be reduced in the presence of organic matter; thoroughly clean the wound before application.

Contraindications

Do not use in patients with a known history of hypersensitivity to benzalkonium chloride or any other component of the formulation.

  • Hypersensitivity to benzalkonium chloride.

Overdose

Overdose from topical application is unlikely due to minimal systemic absorption. Excessive application may lead to intensified local adverse effects, such as severe skin irritation or chemical burns.

In case of accidental ingestion, seek immediate medical attention; symptoms may include gastrointestinal irritation, nausea, vomiting, and abdominal pain. Provide symptomatic and supportive care.

Use in Pregnancy and Lactation

Does not have a negative effect on the course of pregnancy. It is not excreted in breast milk and can be used during breastfeeding.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Manufactured By

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Dosage Form

Bottle OTC Icon Dettol Benzalkonium chloride External use spray 100 mcg: 100 ml g bottle

Dosage Form, Packaging, and Composition

Spray for external use 1 ml
Benzalkonium chloride 0.198 %

100 ml – bottles with a dosing device (1) – cardboard packs.

Marketing Authorization Holder

Reckitt Benckiser Healthcare (UK), Ltd. (United Kingdom)

Manufactured By

Famar Nederland, B.V. (Netherlands)

Dosage Form

Bottle OTC Icon Dettol Benzalkonium chloride External use spray 100 mcg: 100 ml g bottle

Dosage Form, Packaging, and Composition

Spray for external use 1 ml
Benzalkonium chloride 0.198 %

100 ml – bottles with a dosing device (1) – cardboard packs.

TABLE OF CONTENTS