Registered Tanzania · TMDA

GPC8

Didecyldimethylammonium chloride 4.0 - 5.0 % w/v,Glutaraldehyde 12.0 - 13.5 % w/v

TAN 26 AD 0637 INN generic

What it does

Didecyldimethylammonium is a chemical compound often used for its disinfectant properties.

Commonly used for: skin infections, wound care, surface disinfection

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
TAN 26 AD 0637
Registration date
2026-09-30
Expiry date
2031-09-29
Status
Registered/Compliant
Active ingredient
Didecyldimethylammonium chloride 4.0 - 5.0 % w/v,Glutaraldehyde 12.0 - 13.5 % w/v
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
1425983
Manufacturer / MAH
BiTEK Industries Limited
Applicant / LTR
Bitek Industries (Pty) Ltd
Country of origin
SOUTH AFRICA

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-10-08 03:00:44 · updated 2026-10-19 03:00:45

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About didecyldimethylammonium

Didecyldimethylammonium is a chemical compound often used for its disinfectant properties.

What it treats

  • skin infections
  • wound care
  • surface disinfection

How it works

It works by killing bacteria, viruses, and fungi, helping to prevent infections.

Who it's for

It is suitable for individuals needing antiseptic treatment for skin or surfaces.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About glutaraldehyde

Glutaraldehyde is a chemical used mainly for disinfecting and sterilizing medical equipment.

What it treats

  • disinfecting medical instruments
  • sterilizing surgical tools

How it works

It kills bacteria and viruses by breaking down their cellular structures.

Who it's for

This is used by healthcare professionals in hospitals and clinics.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: didecyldimethylammonium

BNF-referenced

Didecyldimethylammonium is a quaternary ammonium compound commonly used as a disinfectant and antiseptic agent. It exhibits antimicrobial properties against a broad spectrum of bacteria, viruses, and fungi. Its ability to disrupt microbial cell membranes makes it effective in various cleaning and sanitizing applications.

Indications

  • Disinfection of surfaces
  • Antiseptic for skin and mucous membranes
  • Sanitization in healthcare settings
  • Use in personal care products

Dosage

Children: For paediatric use, consult BNF for Children for appropriate guidance on formulations and dosages.

Adults: For topical use, apply as directed on the product label. Refer to BNF for specific formulations and concentrations.

Mechanism of action

Didecyldimethylammonium acts primarily by disrupting the lipid bilayer of microbial cell membranes, leading to cell lysis and death. It interacts with negatively charged phospholipids, causing structural damage to the cell membrane, which results in the leakage of cellular contents.

Pharmacodynamics

The pharmacodynamics of didecyldimethylammonium involve its cationic nature, which allows it to bind to negatively charged sites on the microbial surface. This binding alters the permeability of the cell membrane, ultimately leading to the loss of essential intracellular components and cell death. Its effectiveness varies with concentration, contact time, and the type of microorganism.

Pharmacokinetics

Didecyldimethylammonium is typically applied topically and does not undergo significant systemic absorption, which limits its pharmacokinetic profile to local effects. Its persistence on surfaces contributes to its prolonged antimicrobial action. The compound is usually inactivated by organic matter, which can affect its efficacy.

Pregnancy

There are no available data regarding the use of didecyldimethylammonium during pregnancy. Caution is recommended.

Breast-feeding

There is limited information on the excretion of didecyldimethylammonium in human milk. Caution is advised.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • {'formulation': 'Topical solution', 'concentration': '0.1%'}
  • {'formulation': 'Disinfectant', 'concentration': 'Various formulations available'}

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Glutaraldehyde

BNF-referenced

Glutaraldehyde is a potent disinfectant and antiseptic, widely utilized for its efficacy in sterilizing medical instruments and surfaces. It acts as a cross-linking agent, primarily engaging with amino groups in proteins, which facilitates its application in the treatment of certain dermatological conditions such as warts and calluses. Its effectiveness stems from its ability to inactivate microorganisms, making it valuable in both clinical and laboratory settings.

Indications

  • Warts, particularly plantar warts
  • Condylomata acuminata affecting the penis or female external genitalia
  • Sterilization of medical instruments

Dosage

Children: For children aged 2–17 years (initiated under specialist supervision), apply twice daily for 3 consecutive days. Treatment may be repeated at weekly intervals if necessary for a total of four 3-day courses.

Adults: Apply twice daily to the lesion for up to 3 applications, ensuring to remove dead skin before use. Treatment may be repeated weekly if necessary.

Mechanism of action

Glutaraldehyde functions primarily by cross-linking with proteins and nucleic acids, leading to microbial cell death. This cross-linking interferes with the normal functioning of cellular components, thereby disrupting metabolism and replication in bacteria, viruses, and fungi.

Pharmacodynamics

The pharmacodynamic profile of glutaraldehyde is characterized by its rapid action as a broad-spectrum antimicrobial agent. It exhibits bactericidal, virucidal, and fungicidal properties, making it effective against a wide range of pathogens, including resistant strains. Its activity is influenced by concentration, exposure time, and pH levels, with higher concentrations and longer exposure times enhancing its antimicrobial effects.

Pharmacokinetics

Glutaraldehyde is primarily used topically and does not have significant systemic absorption when applied appropriately. It is rapidly metabolized and eliminated from the body. The exact pharmacokinetic parameters, such as half-life or volume of distribution, are not well characterized due to its topical use and rapid inactivation upon contact with tissues.

Contra-indications

  • Not for application to anogenital areas
  • Not for application to the face
  • Not for application to mucosa
  • Avoid broken skin

Adverse effects

  • Skin irritation
  • Rash
  • Balanoposthitis
  • Severe cutaneous adverse reactions
  • Argyria
  • Methaemoglobinaemia

Precautions

  • Avoid application to normal skin
  • Avoid open wounds
  • Keep away from eyes
  • Use under specialist supervision for children

Pregnancy

Avoid use during pregnancy.

Breast-feeding

Avoid use during breastfeeding.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • Warticon 0.5% solution
  • Glutaraldehyde liquid
BNF 85 (British National Formulary) p.1427 BNF for Children 2019-2020 p.812 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: didecyldimethylammonium

PubChem CID 16958

Molecular formula: C22H48N+

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: Glutaraldehyde

PubChem CID 3485

Molecular formula: C5H8O2

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.