International reference: 4 US FDA recalls for this ingredient

Failed Impurities/Degradation Specification; out of specification results for carbon dioxide (available)

Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making t (available)

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

Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval. (available)

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

Registered Tanzania · TMDA

SKIPODINE

POVIDONE IODINE 5%W/V EQUIVALENT TO AVAILABLE IODINE 0.5 %w/w,Polyethylene Glycol (PEG 400) 9.9317 gm,Polyethylene Glycol-4000 4.2058 gm

TAN 26 HM 0029 Ointment 5.0% dermatologicals INN generic

What it does

Available is a medication used for various health conditions. It helps manage symptoms and improve quality of life.

Commonly used for: specific health conditions

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.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
TAN 26 HM 0029
Registration date
2026-02-26
Expiry date
2031-02-25
Status
Registered/Compliant
Active ingredient
POVIDONE IODINE 5%W/V EQUIVALENT TO AVAILABLE IODINE 0.5 %w/w,Polyethylene Glycol (PEG 400) 9.9317 gm,Polyethylene Glycol-4000 4.2058 gm
Dosage form
Ointment
Strength
5.0%
Pack size
-
Therapeutic class
-
ATC class (WHO)
D08AG - Iodine products
Drug group
DERMATOLOGICALS
RxNorm RxCUI
5933
Manufacturer / MAH
Nanz Med Science Pharma
Applicant / LTR
S Kant Healthcare Ltd
Country of origin
INDIA
Manufacturer location
B -214, Industrial Area Phase I, Block C, Naraina Industrial Area Phase 1, Naraina, New Delhi, Delhi 110028, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:46:39 · updated 2026-10-22 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 available

Available is a medication used for various health conditions. It helps manage symptoms and improve quality of life.

What it treats

  • specific health conditions

How it works

Available works by affecting certain processes in the body to help alleviate symptoms related to the conditions it treats.

Who it's for

This medication is for patients who have been prescribed it by their healthcare provider for specific health conditions.

Cautions

  • • Always follow your healthcare provider's instructions.
  • • Inform your doctor about any other medications you are taking.

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

About glycol

Glycol is a substance used in various medical and industrial applications, primarily known for its properties as a solvent and humectant.

What it treats

  • moisturizing skin (topical applications)
  • acting as a solvent in medications

How it works

Glycol helps to retain moisture and can dissolve other substances, making it useful in creams and solutions.

Who it's for

Glycol is generally safe for use in topical products for adults and children when used as directed.

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

About iodine

Iodine is a vital mineral that helps the body produce thyroid hormones, which are essential for metabolism and overall health.

What it treats

  • prevention of iodine deficiency
  • supporting thyroid health
  • treatment of certain thyroid disorders

How it works

Iodine is necessary for the production of thyroid hormones, which help regulate many body functions including growth, metabolism, and energy levels.

Who it's for

Iodine is recommended for people who need to boost their iodine levels, such as those with certain dietary restrictions or thyroid issues.

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

About polyethylene

Polyethylene is a substance often used to relieve constipation by increasing the amount of water in the stool, making it easier to pass.

What it treats

  • constipation
  • bowel obstruction

How it works

It works by drawing water into the intestines, softening the stool and helping it move through the digestive system.

Who it's for

It is suitable for adults and children experiencing constipation or needing to clear their bowels.

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

About povidone

Povidone is a synthetic polymer often used as a disinfectant and to help deliver medications in various forms.

What it treats

  • skin infections
  • wound care
  • eye infections (conjunctivitis)

How it works

Povidone works by killing bacteria and other germs, helping to prevent infections.

Who it's for

Povidone is suitable for people needing treatment for skin or eye infections.

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

Clinical monograph: available

Available is a term that refers to a state where a drug can be accessed and utilized for therapeutic purposes. It encompasses various aspects such as the drug's formulation, pharmacological properties, and regulatory approval for clinical use. Understanding the availability of a drug includes knowledge about its distribution, marketing status, and accessibility in specific regions or countries.

Dosage

Children: Refer to specific clinical guidelines or drug formularies for appropriate paediatric dosing.

Adults: Refer to specific clinical guidelines or drug formularies for appropriate adult dosing.

Mechanism of action

The mechanism of action of a drug is defined by how it interacts with biological systems to produce a therapeutic effect. This can involve binding to specific receptors, inhibiting enzymes, or interfering with cellular processes. The precise mechanism can vary widely depending on the drug's chemical structure and intended use.

Pharmacodynamics

Pharmacodynamics describes the relationship between drug concentration and its effect on the body. It involves studying the drug's efficacy, potency, and therapeutic window. Factors such as receptor affinity, intrinsic activity, and the drug's effect on physiological systems are crucial in understanding pharmacodynamics.

Pharmacokinetics

Pharmacokinetics focuses on the absorption, distribution, metabolism, and excretion (ADME) of a drug. This includes how the body processes the drug from the moment it is administered until it is eliminated from the body. Variations in pharmacokinetics can significantly affect drug efficacy and safety.

Pregnancy

Consult healthcare professionals for advice regarding use during pregnancy. Safety has not been established.

Breast-feeding

Consult healthcare professionals before use while breastfeeding. Safety has not been established.

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: glycol

BNF-referenced

Ethylene glycol, a colorless, odorless liquid with a sweet taste, is primarily used in antifreeze and industrial applications. It is toxic to humans and can lead to severe metabolic acidosis and organ damage upon ingestion. Due to its potential for misuse and toxicity, it is classified as a hazardous substance.

Dosage

Children: Refer to the BNF for Children for appropriate dosing information in paediatric cases, especially in instances of overdose.

Adults: Refer to the BNF for specific dosing information based on clinical circumstances, particularly in cases of overdose.

Mechanism of action

Ethylene glycol is metabolized by alcohol dehydrogenase to glycoaldehyde, which is subsequently converted to glycolic, glyoxylic, and oxalic acids. These metabolites contribute to anion gap metabolic acidosis and are responsible for tissue injury through the formation of insoluble calcium oxalate crystals.

Pharmacodynamics

The toxicity of ethylene glycol arises from its metabolites, particularly glycolic and oxalic acids. These compounds induce metabolic acidosis, lead to renal failure through calcium oxalate crystal deposition in the kidneys, and can cause neurological impairment. The anion gap increases due to the accumulation of these acids, leading to complications such as cardiovascular instability and potential multi-organ failure.

Pharmacokinetics

Ethylene glycol is rapidly absorbed after oral ingestion. It undergoes first-pass metabolism primarily in the liver, where it is converted into its toxic metabolites. The elimination half-life of ethylene glycol varies but is generally prolonged in cases of renal impairment. Renal excretion of metabolites contributes to the duration of toxicity, necessitating prompt medical intervention in cases of overdose.

Adverse effects

  • Metabolic acidosis
  • Renal failure
  • CNS depression
  • Hypocalcemia
  • Cardiovascular collapse
  • Pulmonary edema

Precautions

  • Use with caution in patients with renal impairment
  • Monitor for signs of metabolic acidosis
  • Evaluate electrolyte levels, particularly calcium

Pregnancy

There is limited data on the safety of ethylene glycol in pregnancy. It should only be used if clearly needed.

Breast-feeding

It is unknown if ethylene glycol is excreted in human milk. Caution is advised.

Storage

Store in a tightly closed container at room temperature, away from heat and moisture.

Formulations

  • Liquid

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: iodine

BNF-referenced

Iodine (I2) is a trace element essential for the synthesis of thyroid hormones. It is crucial for normal thyroid function and is involved in various metabolic processes. Iodine supplementation is often used to prevent and treat iodine deficiency disorders, including goiter and hypothyroidism, particularly in areas where dietary intake is insufficient.

Indications

  • Iodine deficiency
  • Goiter
  • Hypothyroidism
  • Thyroiditis
  • Fibrocystic breast disease

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidelines based on age and weight.

Adults: Refer to the BNF for appropriate dosing guidelines based on condition and clinical judgment.

Mechanism of action

Molecular iodine inhibits the induction and promotion of carcinogenesis in mammary tissues and has shown beneficial effects in fibrocystic breast disease. It temporarily decreases thyroid hormone production through the acute Wolff-Chaikoff effect, followed by a return to normal hormone synthesis due to down regulation of the sodium-iodide symport. This mechanism can lead to a transient hypothyroid state in some individuals with underlying thyroid conditions.

Pharmacodynamics

Iodine is vital for the synthesis of thyroid hormones thyroxine (T4) and triiodothyronine (T3). It affects the metabolism of amine-derived hormones and plays a role in amino acid metabolism. The acute excess of iodide can lead to decreased circulating levels of T4 and T3 in susceptible individuals, while most people can escape this effect and maintain normal thyroid function.

Pharmacokinetics

Iodine is absorbed primarily in the gastrointestinal tract and is distributed throughout the body, particularly in the thyroid gland, where it is concentrated for hormone synthesis. The kidney plays a significant role in the excretion of excess iodine. The half-life of iodine in the body varies and can be influenced by dietary intake and underlying health conditions.

Adverse effects

  • Hypothyroidism
  • Hyperthyroidism
  • Iodine allergy
  • Gastrointestinal disturbances

Interactions

  • Thyroid hormones
  • Antithyroid drugs
  • Lithium
  • Diuretics

Precautions

  • Use with caution in patients with thyroid dysfunction
  • Monitor thyroid function periodically during treatment
  • Pregnant or breastfeeding women should consult a healthcare provider before use

Pregnancy

Iodine is essential for fetal thyroid hormone synthesis, but excessive iodine intake should be avoided.

Breast-feeding

Iodine is excreted in breast milk; consult a healthcare provider regarding supplementation.

Storage

Store in a cool, dry place away from light.

Formulations

  • Iodine solution
  • Iodine tincture
  • Potassium iodide tablets

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: polyethylene

Polyethylene is a polymer used primarily as a laxative for the treatment of constipation. It is often administered in the form of polyethylene glycol (PEG), which acts by holding water in the stool, resulting in softer stools and increased bowel movements. It is generally considered safe for use in both adults and children, with minimal side effects when used as directed.

Indications

  • Constipation
  • Bowel preparation prior to surgical procedures or diagnostic tests

Dosage

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

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

Mechanism of action

Polyethylene glycol works by osmotically retaining water in the intestinal lumen, which increases the water content of the stool. This enhances the passage of stool through the intestines and promotes bowel movements. The high molecular weight of polyethylene glycol prevents its absorption in the gastrointestinal tract, ensuring that it remains in the lumen to exert its effects.

Pharmacodynamics

The pharmacodynamic profile of polyethylene glycol involves its ability to increase stool water content, thereby reducing stool consistency and facilitating easier passage. It does not stimulate intestinal motility directly but rather relies on the osmotic effect to promote bowel evacuation. The onset of action typically occurs within 24 to 96 hours after ingestion.

Pharmacokinetics

Polyethylene glycol is not absorbed systemically, and its pharmacokinetics are characterized by its presence solely in the gastrointestinal tract. It is excreted unchanged in the stool. The volume of polyethylene glycol administered can influence the effectiveness and timing of its action, but its absorption is negligible, making systemic side effects rare.

Adverse effects

  • Abdominal cramping
  • Diarrhea
  • Nausea
  • Vomiting
  • Bloating
  • Flatulence

Precautions

  • Use with caution in patients with gastrointestinal disorders or bowel obstruction.
  • Ensure adequate hydration during use to prevent dehydration.

Pregnancy

Polyethylene glycol is generally considered safe during pregnancy, but should be used under medical supervision.

Breast-feeding

Polyethylene glycol is excreted in breast milk in very small amounts and is generally regarded as safe during breastfeeding.

Storage

Store at room temperature, away from moisture and heat.

Formulations

  • Powder for oral solution
  • Liquid formulation

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: povidone

Povidone, also known as polyvinylpyrrolidone (PVP), is a synthetic polymer that is used as a water-soluble binder, stabilizer, and film-forming agent in various pharmaceutical formulations. It is recognized for its ability to enhance the solubility and bioavailability of drugs, making it valuable in both topical and oral therapies. Povidone has antiseptic properties and is commonly used in wound care, surgical scrubs, and as an excipient in medications.

Indications

  • Topical antiseptic for skin disinfection
  • Surgical scrubs and hand sanitizers
  • Wound care management
  • Pharmaceutical excipient in solid and liquid formulations

Dosage

Children: Refer to specific product guidelines for pediatric dosing recommendations, as doses can vary based on formulation and intended use.

Adults: Refer to specific product guidelines for dosing recommendations, as doses can vary based on the formulation and intended use.

Mechanism of action

Povidone acts by forming a complex with iodine when used as an antiseptic, which releases iodine slowly to exert its antimicrobial effect. The iodine disrupts microbial cell walls and interferes with protein synthesis, leading to cell death. Additionally, as a polymer, povidone can enhance drug solubility and stability by forming a hydrophilic matrix.

Pharmacodynamics

Povidone has a broad spectrum of antimicrobial activity against bacteria, viruses, and fungi. Its antiseptic properties are primarily due to the release of iodine, which is effective in reducing microbial load and preventing infection. The polymer's ability to bind to various substances allows it to be utilized in formulations that require improved stability and solubility.

Pharmacokinetics

Povidone is not absorbed systemically when applied topically, as it remains localized at the site of application. Its pharmacokinetics are largely dependent on the formulation and route of administration, with the polymer being metabolized by hydrolysis and excreted in urine as low-molecular-weight compounds. The release and activity of iodine are influenced by the concentration of povidone and the presence of organic matter.

Adverse effects

  • Local irritation
  • Allergic reactions
  • Skin rashes
  • Hypersensitivity reactions

Precautions

  • Use with caution in patients with known allergies to iodine or povidone-iodine
  • Avoid use in deep puncture wounds or serious burns

Pregnancy

Povidone is generally considered safe for use during pregnancy, but it is advisable to consult a healthcare professional before use.

Breast-feeding

Povidone is considered safe during breastfeeding, but it is recommended to consult a healthcare professional.

Storage

Store at room temperature, away from moisture and heat. Keep the container tightly closed.

Formulations

  • Topical solution
  • Ointment
  • Surgical scrub
  • Gauze impregnated with povidone-iodine

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: glycol

PubChem CID 174

Molecular formula: C2H6O2

Mechanism of action

Ethylene glycol is metabolized by alcohol dehydrogenase to glycoaldehyde, which is then metabolized to glycolic, glyoxylic, and oxalic acids. These acids, along with excess lactic acid are responsible for the anion gap metabolic acidosis. Oxalic acid readily precipitates with calcium to form insoluble calcium oxalate crystals. Tissue injury is caused by widespread deposition of oxalate crystals and the toxic effects of glycolic and glyoxylic acids.

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

Molecular reference: iodine

PubChem CID 807

Molecular formula: I2

Mechanism of action

Molecular iodine is known to inhibit the induction and promotion of N-methyl-n-nitrosourea-induced mammary carcinogenesis, to regress 7,12-dimethylbenz(a)anthracene-induced breast tumors in rats.It has also been shown to have beneficial effects in fibrocystic human breast disease. An acute iodide excess (above the preexisting dietary intake) transiently decreases the production of thyroid hormones in the thyroid gland; this is referred to as the acute Wolff-Chaikoff effect. In normal people, this is followed by a return to normal levels of hormone synthesis, referred to as escape from the acute Wolff-Chaikoff effect, without a significant change in circulating hormone levels. Escape is thought to be the result of down regulation of the sodium-iodide symport (NIS), the iodide transporter in the thyroid gland, resulting in a decrease in the intrathyroidal iodine and the resumption of normal hormone synthesis. An acute or chronic excess of iodide can also decrease circulating T4 and T3 levels and induce a hypothyroid state in some people who have underlying thyroid disorders. These effects are the result of a failure to escape from the acute Wolff-Chaikoff effect. Most people who experience iodine-induced hypothyroidism recover when the excess iodine intake is discontinued.

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.