Drugs List

Therapeutic Indications

Uses

Treatment of scaly skin disorders of the scalp such as psoriasis, eczema, seborrhoeic dermatitis and dandruff.

(It has mild antipruritic, antiseptic and keratolytic properties.)

Administration

To be applied to the affected area of the scalp. The product should be washed out with shampoo and warm water approximately 1 hour after application.

Contraindications

Administration site infection
Acute pustular psoriasis
Children under 6 years of age.

Precautions and Warnings

To be used on children aged 6 to 12 years only under medical supervision.

Formulae may differ according to the manufacturer. Although the active ingredients remain the same, the excipients may or may not produce a solid product at room temperature. Some manufacturers may incorporate a perfume.

Avoid contact with the eyes, mouth and mucous membranes and wash hands immediately after use.

Advise patients to seek medical advice if symptoms persist for more than 4 weeks.

Advise patients that coal tar may stain bed linen and jewellery.

Discontinue use if irritation occurs.

The National Patient Safety Agency (NPSA) has issued an alert to all healthcare professionals involved in the prescribing, dispensing and administration of paraffin based skin products that may represent a potential fire risk.

Paraffin based products in contact with dressings and clothing can easily be ignited by a naked flame. This risk is increased when the preparation is applied to a large surface area and where the product has soaked in to clothing or dressings.

Patients should be advised to keep away from fire, naked flames or other potential sources of ignition. Patients should be advised not to smoke when using this preparation.

Patients should receive supplementary information concerning the potential fire risk of smoking or exposure to naked flames during treatment.

Patients and/or relatives should also be counselled regarding the need to regularly change clothing and bedding that may have become impregnated with paraffin based products (preferably on a daily basis).

Patients should also be encouraged to pass on any information regarding their treatment and any associated advice concerning potential fire hazards to their relatives.

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy. The ingredients salicylic acid, sulfur and coal tar, in this product, present a risk.

System absorption of salicylic acid is known to happen following topical application. Animal studies on rats report malformations, but at the time of writing there are no reports of salicylic acid causing malformations in humans. Salicylic acid crosses the placenta. This preparation contains a low dose which should minimise the risks, however caution is advised and prolonged use should be avoided if possible especially near term.

At the time of writing there is no information on the use of topical sulfur in pregnancy. Schaefer, Peters & Miller (2007) suggest that topical sulfur may be used in pregnancy when required but it should be restricted to small areas of skin for short treatment durations.

Data from humans does not suggest any teratogenic effects of coal tar. However, experimentally coal tar products, have to some extent, demonstrated mutagenic or carcinogenic properties. Schaefer, Peters & Miller (2007) suggest that coal tar preparations should ideally not be used in pregnancy, however, accidental use does not require any action.

For these reasons this product should only be used with caution in pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password at https://www.toxbase.org/

Licensed in pregnancy? - No

Recommended for use in pregnancy? - No

Known human teratogen? - Salicylic acid is a known teratogen in high concentrations.

Animal data - Studies on rats have reported malformations after topical salicylic acid use.

Crosses placenta? - Yes, salicylic acid crosses the placenta.

Lactation

Use with caution in nursing mothers. The ingredients salicylic acid, sulfur and coal tar in this product, present a risk.

Salicylic acid is excreted in breast milk, however the affect of this on the infant is unknown.

At the time of writing there is no information on the use of topical sulfur while breastfeeding. Schaefer, Peters & Miller (2007) suggest that topical sulfur may be used in pregnancy when required but it should be restricted to small areas of skin for short treatment durations.

Schaefer, Peters & Miller (2007) suggest that coal tar preparations should not be used while breastfeeding due to their possible mutagenic and carcinogenic effects.

This product should only be used with caution by nursing mothers.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Drug excreted in breast milk? - Salicylic acid is excreted in breast milk.

Considered suitable or recommended by manufacturer? - No.

Drug substance licensed in infants? - No.

Side Effects

Skin irritation
Folliculitis
Photosensitivity
Discolouration of hair
Skin discolouration
Acne-like eruptions
Dermatitis
Alopecia
Bronchospasm
Hypersensitivity reactions

Presentation

Ointment containing 12.0% coal tar solution, 4.0% sulfur and 2.0% salicylic acid in an emollient base containing coconut oil.

Drugs List

Therapeutic Indications

Uses

Treatment of scaly skin disorders of the scalp such as psoriasis, eczema, seborrhoeic dermatitis and dandruff.

(It has mild antipruritic, antiseptic and keratolytic properties.)

Dosage

Adults

Children

Administration

To be applied to the affected area of the scalp. The product should be washed out with shampoo and warm water approximately 1 hour after application.

Contraindications

Administration site infection
Acute pustular psoriasis
Children under 6 years of age.

Precautions and Warnings

To be used on children aged 6 to 12 years only under medical supervision.

Formulae may differ according to the manufacturer. Although the active ingredients remain the same, the excipients may or may not produce a solid product at room temperature. Some manufacturers may incorporate a perfume.

Avoid contact with the eyes, mouth and mucous membranes and wash hands immediately after use.

Advise patients to seek medical advice if symptoms persist for more than 4 weeks.

Advise patients that coal tar may stain bed linen and jewellery.

Discontinue use if irritation occurs.

The National Patient Safety Agency (NPSA) has issued an alert to all healthcare professionals involved in the prescribing, dispensing and administration of paraffin based skin products that may represent a potential fire risk.

Paraffin based products in contact with dressings and clothing can easily be ignited by a naked flame. This risk is increased when the preparation is applied to a large surface area and where the product has soaked in to clothing or dressings.

Patients should be advised to keep away from fire, naked flames or other potential sources of ignition. Patients should be advised not to smoke when using this preparation.

Patients should receive supplementary information concerning the potential fire risk of smoking or exposure to naked flames during treatment.

Patients and/or relatives should also be counselled regarding the need to regularly change clothing and bedding that may have become impregnated with paraffin based products (preferably on a daily basis).

Patients should also be encouraged to pass on any information regarding their treatment and any associated advice concerning potential fire hazards to their relatives.

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy. The ingredients salicylic acid, sulfur and coal tar, in this product, present a risk.

System absorption of salicylic acid is known to happen following topical application. Animal studies on rats report malformations, but at the time of writing there are no reports of salicylic acid causing malformations in humans. Salicylic acid crosses the placenta. This preparation contains a low dose which should minimise the risks, however caution is advised and prolonged use should be avoided if possible especially near term.

At the time of writing there is no information on the use of topical sulfur in pregnancy. Schaefer, Peters & Miller (2007) suggest that topical sulfur may be used in pregnancy when required but it should be restricted to small areas of skin for short treatment durations.

Data from humans does not suggest any teratogenic effects of coal tar. However, experimentally coal tar products, have to some extent, demonstrated mutagenic or carcinogenic properties. Schaefer, Peters & Miller (2007) suggest that coal tar preparations should ideally not be used in pregnancy, however, accidental use does not require any action.

For these reasons this product should only be used with caution in pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password at https://www.toxbase.org/

Licensed in pregnancy? - No

Recommended for use in pregnancy? - No

Known human teratogen? - Salicylic acid is a known teratogen in high concentrations.

Animal data - Studies on rats have reported malformations after topical salicylic acid use.

Crosses placenta? - Yes, salicylic acid crosses the placenta.

Lactation

Use with caution in nursing mothers. The ingredients salicylic acid, sulfur and coal tar in this product, present a risk.

Salicylic acid is excreted in breast milk, however the affect of this on the infant is unknown.

At the time of writing there is no information on the use of topical sulfur while breastfeeding. Schaefer, Peters & Miller (2007) suggest that topical sulfur may be used in pregnancy when required but it should be restricted to small areas of skin for short treatment durations.

Schaefer, Peters & Miller (2007) suggest that coal tar preparations should not be used while breastfeeding due to their possible mutagenic and carcinogenic effects.

This product should only be used with caution by nursing mothers.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Drug excreted in breast milk? - Salicylic acid is excreted in breast milk.

Considered suitable or recommended by manufacturer? - No.

Drug substance licensed in infants? - No.

Effects on Ability to Drive and Operate Machinery

None known.

Counselling

Advise patients that coal tar may stain bed linen and jewellery.
Advise patients to avoid contact with the eyes, mouth and mucous membranes and to wash hands immediately after use.
Advise patients to seek medical advice if symptoms persist for more than 4 weeks.
Discontinue use if irritation occurs.
Patients should be advised to keep away from fire, naked flames or other potential sources of ignition.
Patients should be advised not to smoke when using this preparation.
Patients and/or relatives should also be counselled regarding the need to regularly change clothing and bedding that may have become impregnated with paraffin based products (preferably on a daily basis).
Patients should also be encouraged to pass on any information regarding their treatment and any associated advice concerning potential fire hazards to their relatives.

Side Effects

Skin irritation
Folliculitis
Photosensitivity
Discolouration of hair
Skin discolouration
Acne-like eruptions
Dermatitis
Alopecia
Bronchospasm
Hypersensitivity reactions

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet (https://www.toxbase.org/)

Shelf Life and Storage

Store at a temperature between 10 and 25 degrees C.

Do not refrigerate

Reference Sources

Summary of Product Characteristics: Cocois Coconut Oil Compound. UCB Pharma Ltd. Revised May 2015.

Summary of Product Characteristics: Sebco. Derma UK Ltd. Revised July 2016.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 7th edition (2005) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Therapeutics in Pregnancy and Lactation (2000) Lee, A., Inch, S. and Finnigan, D. Radcliffe Medical Press, Abingdon.

Drugs and Lactation Database, LactMed, Aspirin record, Revised 27th December 2007.
Available at https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Accessed 16th June 2008.

Clinical Knowledge Summary - Warts (including verrucas), Published January 2007.
Available at https://www.cks.library.nhs.uk/warts_including_verrucas#-243429
Accessed 17th June 2008.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 31 August 2017