International reference: 4 US FDA recalls for this ingredient

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. (precipitate)

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. (precipitate)

Presence of Precipitate; precipitation of drug product (precipitate)

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. (precipitate)

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

Registered Tanzania · TMDA

SABUSOL (Sulfur Soap)

Sulphur precipitate 10 %

TAN 21 AD 0515

What it does

Precipitate is a substance that can form when certain ingredients combine in a solution. It is not a medication but may be related to the preparation of certain medicines.

Read more in plain English ↓

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

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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 21 AD 0515
Registration date
2021-12-30
Expiry date
2026-12-29
Status
Registered/Compliant
Active ingredient
Sulphur precipitate 10 %
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Kavit Soap Industries
Applicant / LTR
GENERICS & SPECIALITIES LTD
Country of origin
INDIA
Manufacturer location
207 Eventi Complex, Nr Hotel Dev Corporate, Nr Girish Cold Drink cross road, Opp, Chimanlal Girdharlal Rd, Sardar Patel Nagar, Navrangpura, Ahmedabad, Gujarat 380006, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:37:41 · updated 2026-10-26 03:00:43

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

About precipitate

Precipitate is a substance that can form when certain ingredients combine in a solution. It is not a medication but may be related to the preparation of certain medicines.

How it works

Precipitation occurs when dissolved substances come together to form solid particles that separate from the liquid.

Who it's for

This information is relevant for healthcare professionals involved in medication preparation, not for general patients.

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

About sulphur

Sulphur is a natural substance commonly used in skin treatments. It helps to improve various skin conditions.

What it treats

  • acne
  • seborrheic dermatitis
  • scabies

How it works

Sulphur works by reducing oiliness and helping to kill bacteria on the skin, promoting healing.

Who it's for

Sulphur is for people dealing with certain skin problems like acne or scabies.

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

Clinical monograph: precipitate

Precipitate refers to a solid that forms and separates from a solution, often as a result of a chemical reaction. In a pharmacological context, it can occur when two or more drugs interact, leading to the formation of an insoluble compound. This phenomenon can impact drug efficacy and safety, particularly in intravenous formulations. Understanding the conditions under which precipitates form is crucial for ensuring proper drug administration and avoiding complications.

Dosage

Children: Refer to specific drug guidelines and compatibility charts, as dosing may vary based on the formulation and presence of precipitates.

Adults: Refer to specific drug guidelines and compatibility charts, as dosing may vary based on the formulation and presence of precipitates.

Mechanism of action

The formation of a precipitate typically results from a change in solubility due to factors such as pH, temperature, or concentration of reactants. In a clinical setting, the interaction between drugs can lead to the formation of insoluble complexes, which can decrease the bioavailability of the drugs involved. This mechanism underscores the importance of compatibility in drug formulations.

Pharmacodynamics

Pharmacodynamics involves the study of how drugs affect biological systems. In the case of precipitate formation, the interaction between different drugs may alter their pharmacodynamics by reducing the effective concentration of the active ingredients. This can lead to subtherapeutic effects or an unexpected increase in adverse effects, depending on the drugs involved and their mechanisms of action.

Pharmacokinetics

Pharmacokinetics refers to the absorption, distribution, metabolism, and excretion of drugs. When a precipitate forms, the absorption of the drug can be impaired, leading to decreased systemic exposure. The distribution may also be affected if the precipitate alters the drug's solubility characteristics. Additionally, the metabolism and excretion of the affected drugs may change, potentially resulting in altered therapeutic outcomes.

Pregnancy

Use of precipitate should be carefully considered in pregnancy. Consult a healthcare professional for risk assessment.

Breast-feeding

Consult a healthcare professional before using precipitate while breastfeeding.

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: sulphur

BNF-referenced

Sulfur is a non-metallic element widely used in dermatological preparations due to its keratolytic, antibacterial, and antifungal properties. It is primarily applied topically for the treatment of various skin conditions, including acne and scabies. Its efficacy is attributed to the formation of active compounds that exert germicidal activity and facilitate the shedding of dead skin cells, making it a valuable agent in managing certain skin disorders.

Indications

  • Acne vulgaris
  • Scabies
  • Seborrheic dermatitis
  • Dandruff
  • Pityriasis versicolor

Dosage

Children: Refer to

Adults: Refer to specific product instructions or BNF for appropriate topical application guidance.

Mechanism of action

Topically applied sulfur has mild antifungal and antibacterial activity. It is believed that sulfur forms hydrogen sulfide and/or polythionic acid upon application, which may exert germicidal effects. In vitro studies suggest that sulfur's antifungal activity is primarily due to its keratolytic action, which leads to the shedding of fungal spores and hyphae. The drug exhibits potent inhibitory effects against some streptococci and moderate effects against Staphylococcus aureus, while showing no activity against gram-negative bacteria. Its antibacterial effects may also result from the inactivation of sulfhydryl groups in bacterial enzyme systems. Additionally, sulfur is toxic to Sarcoptes scabiei, the parasite responsible for scabies.

Pharmacodynamics

Sulfur's pharmacodynamic properties include its keratolytic action, which helps in exfoliating the outer layer of skin and reducing the build-up of keratin. The antibacterial and antifungal activities contribute to its effectiveness against skin infections and conditions like acne. The exact pharmacodynamic pathways are not fully defined, but the combination of keratolytic, antibacterial, and antifungal effects underpins its therapeutic use in dermatology.

Pharmacokinetics

Sulfur is primarily used topically, and as such, its systemic absorption is minimal. Its local effects are achieved through direct application to the skin, where it acts on the surface and within the stratum corneum. The pharmacokinetics of sulfur involve minimal penetration into systemic circulation, leading to a lower risk of systemic side effects. The onset of action is relatively quick due to its localized effects.

Adverse effects

  • Skin irritation
  • Dryness
  • Stinging
  • Redness
  • Peeling

Precautions

  • Use with caution in patients with sensitive skin
  • Avoid contact with eyes and mucous membranes
  • Discontinue use if severe irritation occurs

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the benefits outweigh the risks.

Breast-feeding

It is unknown if sulfur is excreted in human milk. Caution should be exercised when administered to a nursing woman.

Storage

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

Formulations

  • Topical cream
  • Topical ointment
  • Topical lotion
  • Topical soap

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: sulphur

PubChem CID 5362487

Molecular formula: S

Mechanism of action

Topically applied sulfur has mild antifungal and antibacterial activity. It has been suggested that when applied topically to the skin, sulfur forms hydrogen sulfide and/or polythionic acid, which may exert germicidal activity. In vitro studies indicate that sulfur has little if any fungistatic or fungicidal activity. Therefore, sulfur's antifungal activity probably results largely from its keratolytic action, causing shedding of fungal spores and hyphae embedded within the stratum corneum. In vitro, sulfur has been shown to have some antibacterial activity; the drug has a potent inhibitory effect against some streptococci, a moderate inhibitory effect against Staphylococcus aureus, and no activity against gram-negative bacteria. It has been suggested that the drug's antibacterial activity may partly result from inactivation of sulfhydryl groups contained in bacterial enzyme systems, since the antibacterial effect of the drug has reportedly been neutralized by addition of cysteine and other sulfhydryl-containing compounds to the culture medium. Topically applied sulfur is reportedly toxic to the parasitic arthropod Sarcoptes scabiei. The exact mechanism(s) of action of "sulfur" in the treatment of acne is not fully understood but is presumed to involve the drug's keratolytic and antibacterial effects. Although some studies indicate that "sulfur" may also be comedogenic, other studies have been unable to substantiate this effect and the drug generally is considered effective in the topical treatment of acne. The aim of this research was to analyze the effects and the modes of action of elemental sulfur (S(0)) in bioluminescence and respiration of Vibrio fischeri cells and the enzymes crude luciferase, pure catalase, and alcohol dehydrogenase (ADH). Metallic copper removed sulfur and reduced the toxicity of acetone extracts of sediment samples analyzed in the bioluminescence test. The sulfur inhibition of cell bioluminescence was noncompetitive with decanal, the luciferase substrate; reversible, with maximum toxicity after 15 min (EC50 = 11.8 ug/L); and almost totally recovered after 2 hr. In vitro preincubation of crude luciferase extract with sulfur (0.28 ppm) weakly inhibited bioluminescence at 5 min, but at 30 min the inhibition reached 60%. Increasing the concentration of sulfur in the parts per million concentration range in vitro decreased bioluminescence, which was not constant, but depended on exposure time, and no dead-end/total inhibition was observed. The redox state of enzymes in the in vitro system significantly affected inhibition. Hydrogen peroxide restored fully and the reducing agent dithiothreitol, itself toxic, restored only partially luciferase activity in the presence of sulfur. Sulfur (5.5 ppm) slightly inhibited ADH and catalase, and dithiothreitol enhanced sulfur inhibition. High sulfur concentrations (2.2 ppm) inhibited the bioluminescence and enhanced the respiration rate of V. fischeri cells. Elemental sulfur data were interpreted to show that sulfur acted on at least a few V. fischeri cell sites: reversibly modifying luciferase at sites sensitive to/protected by oxidative and reducing agents and by affecting electron transport processes, resulting in enhanced oxygen consumption. Sulfur together with an enzyme reducing agent inhibited the oxidoreductive enzymes ADH and catalase, which have /thiol/ groups, metal ion cofactors, or heme, respectively, in their active centers. Sulfur must be converted to pentathionic acid (H2S5O6) in order to exert germicidal action. Presumably oxidation of sulfur to pentathionic acid is accomplished by certain microorganisms or by epidermal cells when element is applied to skin. Sulfur possesses a keratolytic property, which may be the basis for the therapeutic action of the element in certain cutaneous disorders unassociated with infection.

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.