1. Name Of The Medicinal Product
DDD Medicated Cream
2. Qualitative And Quantitative Composition
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For excipients, see 6.1.
3. Pharmaceutical Form
Cream.
White cream
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment and symptomatic relief of spots, pimples, minor rashes, cuts and grazes, and other minor skin problems.
4.2 Posology And Method Of Administration
For minor skin problems: apply at least each morning and evening.
For spots and pimples: apply regularly until skin is clear.
Minor skin problems, cuts and grazes: cleanse the area with warm water to remove all dirt. Rub DDD Medicated Cream well into affected part. Apply at least each morning and evening to help speed healing.
Spots and pimples: wash and dry the skin thoroughly then apply DDD Medicated Cream regularly until your skin is clear.
Minor rashes: minor rashes are quickly soothed by regular use of DDD Medicated Cream. If necessary apply a bandage or plaster.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
4.4 Special Warnings And Precautions For Use
For external use only.
If symptoms persist consult your doctor.
Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
There are no restrictions on the use of DDD Medicated Cream in pregnancy and lactation.
4.7 Effects On Ability To Drive And Use Machines
None.
4.8 Undesirable Effects
None known.
4.9 Overdose
Used as a topical cream, there are no reported instances of adverse reactions due to the over liberal application of this product.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
DDD Medicated Cream contains well-established active ingredients with antiseptic, analgesic and soothing properties presented in a smooth cream base. The base is readily dispersible for ease of application at the site of the skin problem. The active ingredients comprise:
Thymol: a phenolic antiseptic with antibacterial and antifungal activity, which can be applied topically for the treatment of skin disorders.
Levomenthol : the active enantiomer of menthol, it interacts directly with coldness receptors in the skin. As well as its cooling properties, levomenthol also has antipruritic activities and counter-irritant effects.
Methyl salicylate: a counter-irritant, traditionally known as Oil of Wintergreen, widely used as a rubefacient in topical preparations.
Chlorobutanol: has antimicrobial properties, and has also been used therapeutically for its mild sedative and local analgesic effects.
Titanium dioxide: when applied to the skin has actions similar to those of zinc oxide, i.e. mildly astringent, soothing and protective.
5.2 Pharmacokinetic Properties
As this product has been in widespread use for many years, no specific pharmacokinetic studies have been performed. The pharmacokinetic profiles of the individual active ingredients are outlined below:
Thymol: little is known of the pharmacokinetic profile of thymol following topical administration. Orally administered thymol is absorbed from the GI tract and is excreted in the urine as unchanged drug and as the glucuronide.
Levomenthol: appears to be absorbed through the skin, and is excreted via the urinary and biliary routes as the glucuronide.
Methyl salicylate: has been shown to be rapidly absorbed through the skin, although GI absorption may be delayed for several hours. Dermal absorption may be enhanced by heat and exercise, and may also increase with multiple dosing. Salicylates are excreted mainly in the urine.
Chlorobutanol: the extent of absorption of Chlorobutanol via the skin is not known. However, after oral doses peak plasma concentrations are rapidly attained, followed by a prolonged terminal half-life of approximately 10 days.
Titanium dioxide: there is lack of data on the cutaneous absorption of titanium dioxide. However, there is some evidence to show that titanium is detectable in the dermis following repeated topical administration.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium hydroxide
Sorbitan stearate
Polyoxyl 40 Stearate
Propylene glycol
Stearic acid
Cetostearyl alcohol
Light liquid paraffin
White soft paraffin
Purified water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
4 years.
6.4 Special Precautions For Storage
No special precautions for storage.
6.5 Nature And Contents Of Container
18 g tube with screw cap.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
DDD Limited,
94, Rickmansworth Road
Watford
Hertfordshire WD18 7JJ
United Kingdom
8. Marketing Authorisation Number(S)
PL 0133/5006R
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of last renewal: 27.08.98
10. Date Of Revision Of The Text
November 2003
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