International reference: 1 US FDA recall for this ingredient

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. (surfactant)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Tanzania.

Registered Tanzania · TMDA

Ditol Solution 4.8%

Amaranth Powder 2.0 gm,Caramel 0.03 gm,Chloroxylenol Surfactant Complex 15% 3300.0 ml,Purified Water q.s to 10.0 Ltr ml,Sodium Lauryl Sulfate 66.0 gm

TAN 25 AD 0355 Topical Solution 4.8 dermatologicals INN generic

What it does

Amaranth is a natural substance often used as a dietary supplement.

Commonly used for: nutritional support, improving digestive health, boosting overall wellness

Read more in plain English ↓

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

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
TAN 25 AD 0355
Registration date
2025-07-25
Expiry date
2026-07-24
Status
Registered/Compliant
Active ingredient
Amaranth Powder 2.0 gm,Caramel 0.03 gm,Chloroxylenol Surfactant Complex 15% 3300.0 ml,Purified Water q.s to 10.0 Ltr ml,Sodium Lauryl Sulfate 66.0 gm
Dosage form
Topical Solution
Strength
4.8
Pack size
-
Therapeutic class
-
ATC class (WHO)
D08AE - Phenol and derivatives
Drug group
DERMATOLOGICALS
RxNorm RxCUI
20877
Manufacturer / MAH
Cure Afya
Country of origin
TANZANIA
Manufacturer location
Kimbiji, Tanzania

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:52:17 · updated 2026-07-23 03:00:41

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

About amaranth

Amaranth is a natural substance often used as a dietary supplement.

What it treats

  • nutritional support
  • improving digestive health
  • boosting overall wellness

How it works

Amaranth contains nutrients that may help improve health and support the body's functions.

Who it's for

Adults looking for nutritional supplements or those who want to enhance their diet.

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

About caramel

Caramel is often used as a coloring agent in foods and medicines. It adds a sweet flavor and enhances the appearance of products.

What it treats

  • food coloring
  • flavoring agent

How it works

Caramel is made by heating sugar, which gives it a brown color and sweet taste.

Who it's for

Caramel can be consumed by most people, but those with specific dietary restrictions or allergies should check product labels.

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

About chloroxylenol

Chloroxylenol is an antiseptic used to clean and disinfect skin and surfaces.

What it treats

  • skin infections
  • minor cuts and scrapes
  • disinfection of skin before procedures

How it works

Chloroxylenol kills germs and prevents the growth of bacteria on the skin.

Who it's for

It is suitable for anyone needing to clean minor wounds or disinfect their skin.

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

About complex

Complex is a medication used to treat various health conditions. It works in the body to help improve symptoms.

How it works

Complex helps the body by influencing certain processes to improve health.

Who it's for

This medication is for individuals with specific health conditions as determined by a healthcare provider.

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

About lauryl

Lauryl is a compound used in various products, known for its cleansing properties.

What it treats

  • skin cleansing
  • oral hygiene

How it works

Lauryl works by helping to remove dirt and oils from the skin and mouth.

Who it's for

Lauryl is suitable for people looking for effective cleansing products for their skin or oral health.

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

About ltr

LTR is a medication used primarily to manage certain health conditions.

What it treats

  • specific health condition (name not provided)

How it works

LTR works by affecting certain processes in the body to help manage symptoms.

Who it's for

LTR is intended for adults and children with the prescribed condition.

Cautions

  • • Consult your doctor if you have any allergies or are taking other medications.

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

About purified

Purified ingredients are often used in various medicines to ensure safety and effectiveness by removing impurities.

What it treats

  • various medical conditions

How it works

Purified ingredients help in delivering the intended effects of the medicine without the risk of contaminants.

Who it's for

People who need medications with safe and effective ingredients.

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

About surfactant

Surfactants are substances that help reduce surface tension in liquids. They are often used in medical treatments to improve the ability of certain medications to work effectively.

What it treats

  • respiratory distress syndrome
  • lung conditions requiring improved gas exchange

How it works

Surfactants work by lowering the surface tension in the lungs, making it easier for the air sacs to expand and function properly.

Who it's for

Surfactants are typically used for newborns with breathing difficulties and adults with certain lung issues.

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

Clinical monograph: amaranth

BNF-referenced

Amaranth is a synthetic dye belonging to the azo dye class, primarily used in food and cosmetics. Its molecular formula is C20H11N2Na3O10S3. Amaranth is known for its bright red color and is often utilized in various applications due to its stability and colorfastness. It is classified as a non-permitted color additive in some regions, including the European Union, due to concerns regarding its safety and potential health effects.

Mechanism of action

Amaranth, as an azo dye, exerts its effect primarily through its interaction with cellular components, where it can bind to proteins and nucleic acids. This interaction can lead to changes in cellular functions and may induce oxidative stress. The exact pathways of its action are not fully elucidated, but it is believed to influence metabolic processes related to color stability and absorption in various mediums.

Pharmacodynamics

The pharmacodynamics of amaranth involves its role as a coloring agent. It does not possess pharmacological activity in the traditional sense, as it is not used for therapeutic purposes. The dye's stability in acidic and neutral conditions allows it to retain its color in food products, but it does not interact with biological systems in a manner that would produce a pharmacological response.

Pharmacokinetics

The pharmacokinetic profile of amaranth is not well defined due to its nature as a food additive rather than a pharmaceutical compound. However, it is generally assumed that upon consumption, amaranth can be absorbed in the gastrointestinal tract, potentially metabolized in the liver, and excreted via the kidneys. The extent of absorption and metabolism may vary based on individual factors and the form in which it is ingested.

Pregnancy

Safety in pregnancy has not been established. Use with caution and only if clearly needed.

Breast-feeding

Safety during breastfeeding is not established. Consult healthcare provider before use.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

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: caramel

BNF-referenced

Caramel is a complex mixture of compounds created by the controlled heat treatment of sugars. It is commonly used as a food coloring and flavoring agent, imparting a characteristic brown color and sweet flavor to various food products. Caramel is widely utilized in the food industry and is generally recognized as safe (GRAS) by regulatory agencies.

Indications

  • Food coloring
  • Flavoring agent
  • Culinary applications

Dosage

Children: Refer to food product specifications, as dosage varies based on application. No specific therapeutic dose exists.

Adults: Refer to food product specifications, as dosage varies based on application. No specific therapeutic dose exists.

Mechanism of action

Caramel's mechanism of action primarily involves its role as a colorant and flavor enhancer in food products. The heating process leads to the breakdown of sugar molecules, resulting in the formation of various compounds that contribute to its color and taste. These compounds may also interact with taste receptors, enhancing the sensory experience of food.

Pharmacodynamics

Caramel does not have pharmacological effects in the traditional sense, as it is primarily a food additive. Its primary role is to provide color and flavor to foods rather than exerting therapeutic effects. However, it can influence the palatability of food items, potentially affecting food intake and enjoyment.

Pharmacokinetics

As a food additive, caramel is generally not absorbed in significant quantities in the gastrointestinal tract. It is metabolized by gut bacteria and may be broken down into simple sugars and other metabolites. The exact metabolic pathway is not well defined, as caramel is considered a complex mixture rather than a single compound.

Pregnancy

Caramel is generally regarded as safe for consumption during pregnancy when used in food products.

Breast-feeding

Caramel is considered safe during breastfeeding when consumed in moderate amounts as part of food.

Storage

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

Formulations

  • Liquid caramel
  • Caramel powder
  • Caramel syrup

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: chloroxylenol

BNF-referenced

Chloroxylenol is a substituted phenol known for its antiseptic properties. It is primarily used in various antiseptic and disinfectant formulations for external use. Chloroxylenol exhibits bactericidal activity against a broad spectrum of Gram-positive and Gram-negative bacteria, making it a valuable agent in infection control and hygiene practices.

Indications

  • Antiseptic for skin disinfection
  • Hygiene products
  • Infection control in healthcare settings

Dosage

Children: Refer to specific product guidelines for appropriate concentrations and application methods.

Adults: Refer to specific product guidelines for appropriate concentrations and application methods.

Mechanism of action

As a phenol antiseptic, chloroxylenol is believed to interact with bacterial cell membranes through its hydroxyl (-OH) groups. This interaction disrupts the membrane integrity, causing cellular contents to leak out. Chloroxylenol further penetrates the bacterial cell, binding to proteins and enzymes, thereby impairing cellular function. At high concentrations, chloroxylenol can coagulate proteins and nucleic acids within the bacterial cells, leading to rapid cell death.

Pharmacodynamics

Chloroxylenol displays bactericidal properties at low concentrations, effectively targeting a wide range of bacteria. Its mechanism of action includes disrupting bacterial cell membranes and interfering with essential cellular processes, which contributes to its effectiveness as an antimicrobial agent in antiseptic and disinfectant applications.

Pharmacokinetics

The pharmacokinetics of chloroxylenol, including absorption, distribution, metabolism, and excretion, are not extensively documented. However, as an agent used primarily for external application, systemic absorption is minimal, and its effects are localized. Further studies may be required to fully elucidate its pharmacokinetic profile.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Chloroxylenol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Chloroxylenol is excreted in breast milk. Caution should be exercised when administering to nursing mothers.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Topical solution
  • Cream
  • Liquid antiseptic

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: complex

Complex refers to a category of pharmacological agents that interact with various biological systems to produce therapeutic effects. These compounds often consist of multiple components, which may enhance efficacy or reduce side effects. Their exact classification and specific therapeutic uses depend on the individual agent.

Dosage

Children: Refer to specific drug guidelines or BNF for Children for accurate dosing information.

Adults: Refer to specific drug guidelines or BNF for accurate dosing information.

Mechanism of action

The mechanism of action of complex drugs can vary widely depending on their composition. Generally, these agents may act by modulating receptor activity, inhibiting enzyme pathways, or altering cellular signaling pathways. For instance, they may function as agonists or antagonists at specific receptors, influencing physiological responses such as neurotransmission or inflammation.

Pharmacodynamics

The pharmacodynamics of complex drugs involves understanding how they affect the body over time, including their potency, efficacy, and duration of action. These drugs may exhibit dose-dependent effects, where higher doses lead to increased therapeutic actions or side effects. Additionally, the interactions between the components of a complex formulation can result in synergistic or antagonistic effects, impacting the overall therapeutic outcome.

Pharmacokinetics

Pharmacokinetics of complex drugs encompasses the absorption, distribution, metabolism, and excretion (ADME) of the drug components. Absorption can be influenced by the formulation, while distribution may vary based on the lipophilicity and protein binding of each component. Metabolism often occurs in the liver, with various enzymes involved, and excretion typically takes place via renal or biliary pathways. The half-life of complex drugs can vary significantly based on their individual components.

Pregnancy

Consult healthcare provider. Risk-benefit assessment is essential before use.

Breast-feeding

Consult healthcare provider. Monitor for potential effects on the infant.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

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: lauryl

Lauryl, also known as lauryl sulfate, is a surfactant and cleansing agent commonly used in various pharmaceutical and cosmetic formulations. It is derived from lauric acid, a medium-chain fatty acid found in coconut oil and palm kernel oil. Lauryl sulfate is primarily utilized for its ability to create lather and enhance the solubility of active ingredients in topical applications. Its use is widespread in shampoos, body washes, and other personal care products.

Indications

  • Cleansing agent in topical formulations
  • Emulsifying agent in cosmetic products
  • Foaming agent in shampoos and body washes

Dosage

Children: Refer to specific product formulations for appropriate concentrations and application methods.

Adults: Refer to specific product formulations for appropriate concentrations and application methods.

Mechanism of action

Lauryl sulfate functions as an anionic surfactant. It reduces the surface tension between different substances, allowing for better spreading and wetting. In the context of cleansing, it facilitates the removal of dirt and oils from the skin and hair by emulsifying these substances, thus making them easier to rinse away with water.

Pharmacodynamics

As a surfactant, lauryl sulfate displays properties that can disrupt cellular membranes and alter permeability. This mechanism is beneficial in enhancing the penetration of other therapeutic agents in topical formulations. However, its irritant potential on skin and mucous membranes should be noted, as it can lead to dryness and irritation with prolonged exposure.

Pharmacokinetics

Lauryl sulfate is primarily applied topically and is not intended for systemic absorption. When used in formulations, it acts locally at the site of application. Its absorption through the skin is minimal, and any systemic exposure is limited. Metabolism and excretion pathways are not well-defined for topical applications, as it is largely washed away after use.

Pregnancy

Safety during pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Unknown whether lauryl is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

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: purified

Purified refers to a substance that has been processed to remove impurities, contaminants, or unwanted substances, resulting in a more concentrated and effective form of the original compound. In pharmacology, purified compounds are often used to enhance therapeutic efficacy and reduce adverse effects. The purification process can apply to a variety of substances, including drugs, biological products, and chemical compounds.

Dosage

Children: Refer to specific drug formulations and product labels as purified substances can vary widely in their use and dosing.

Adults: Refer to specific drug formulations and product labels as purified substances can vary widely in their use and dosing.

Mechanism of action

The mechanism of action for purified compounds varies widely depending on the specific substance. Generally, purified drugs exert their effects by interacting with specific biological targets, such as receptors, enzymes, or ion channels, leading to a desired therapeutic effect. This interaction can involve binding to receptors to activate or inhibit signaling pathways, modulating enzymatic activity, or altering physiological processes.

Pharmacodynamics

Pharmacodynamics describes the effects of a drug on the body and the relationship between drug concentration and effect. For purified drugs, this can involve dose-response relationships and the time course of their action. The purified form often enhances potency and reduces variability in response among patients, which can lead to more predictable therapeutic outcomes. The overall effect is determined by the drug's affinity for its target, the efficacy of the drug-receptor interaction, and the downstream signaling pathways activated as a result of this interaction.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of a drug. For purified substances, absorption can be more efficient due to the absence of impurities that may affect solubility or stability. Distribution may also be enhanced, leading to higher bioavailability. Metabolism can be influenced by the structure of the purified compound, as it may be metabolized more readily by liver enzymes. Excretion typically occurs through the kidneys or liver, depending on the molecular characteristics of the purified drug.

Pregnancy

Consult with a healthcare professional, as the safety of purified forms of medications during pregnancy may vary depending on the specific substance.

Breast-feeding

Consult with a healthcare professional, as the safety of purified forms of medications during breastfeeding may vary depending on the specific substance.

Storage

Store in a cool, dry place, away from light and moisture, and keep out of reach of children.

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: surfactant

Surfactants are compounds that lower the surface tension of liquids, facilitating the spread of fluid in the lungs and improving gas exchange. They are composed of phospholipids and proteins and play a crucial role in maintaining alveolar stability, preventing atelectasis, and enhancing lung function, particularly in premature infants with respiratory distress syndrome (RDS). Surfactants are administered intratracheally and are essential in the management of neonatal respiratory conditions.

Indications

  • Neonatal respiratory distress syndrome (RDS)
  • Prevention of atelectasis in premature infants
  • Treatment of meconium aspiration syndrome

Dosage

Children: Refer to the BNF for Children for specific dosing protocols.

Mechanism of action

Surfactants act by reducing surface tension at the air-liquid interface within the alveoli, which prevents collapse during expiration and improves compliance of the lung tissue. The primary component, dipalmitoylphosphatidylcholine (DPPC), aligns at the surface, stabilizing the alveoli and promoting effective gas exchange. This mechanism is vital in conditions where surfactant deficiency occurs, such as neonatal RDS.

Pharmacodynamics

Surfactants enhance lung compliance, reduce the work of breathing, and improve oxygenation. By decreasing surface tension, they prevent the collapse of alveoli (atelectasis), leading to better ventilation and perfusion matching in the lungs. This results in improved gas exchange and reduced reliance on mechanical ventilation in neonates with RDS.

Pharmacokinetics

Surfactants are administered directly into the trachea, where they rapidly distribute throughout the alveolar surface. They are metabolized in the lungs and cleared via alveolar macrophages and the lymphatic system. The half-life varies based on formulation and individual patient factors, but they are generally cleared from the lungs within hours.

Adverse effects

  • Respiratory distress
  • Hypoxia
  • Bradycardia
  • Desaturation
  • Pulmonary hemorrhage
  • Air leak syndromes

Precautions

  • Caution in patients with a history of lung disease
  • Monitor for signs of respiratory distress post-administration
  • Careful handling to avoid contamination

Pregnancy

Surfactants are generally considered safe for use during pregnancy when indicated.

Breast-feeding

Minimal risk to breastfeeding infants, but caution is advised.

Storage

Store at 2 to 8 degrees Celsius. Do not freeze. Protect from light.

Formulations

  • Poractant alfa (Curosurf)
  • Beractant (Survanta)
  • Calfactant (Infasurf)

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: amaranth

PubChem CID 13506

Molecular formula: C20H11N2Na3O10S3

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

Molecular reference: caramel

PubChem CID 61634

Molecular formula: C7H10O2

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

Molecular reference: chloroxylenol

PubChem CID 2723

Molecular formula: C8H9ClO

Mechanism of action

As a phenol antiseptic, it is believed that the hydroxyl -OH groups of the chloroxylenol molecule binds to certain proteins on the cell membrane of bacteria, and disrupts the membrane so as to allow the contents of the bacterial cell to leak out. This allows chloroxylenol to enter the bacterial cell to bind further with more proteins and enzymes to disable the cell's functioning. At particularly high concentrations of chloroxylenol, the protein and nucleic acid content of targeted bacterial cells become coagulated and cease to function, leading to rapid cell death.

Pharmacodynamics

Chloroxylenol is a substituted phenol which has been widely used for many years as an ingredient of antiseptic and disinfectant products intended for external use. It is known to be bactericidal in low concentration to a wide range of Gram positive and Gram negative bacteria.

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

Molecular reference: laurylsulfate

PubChem CID 8778

Molecular formula: C12H26O4S

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.