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SYMBA SKIN TONER 2%

Active substance(s): HYDROQUINONE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Symba Skin Toner Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroquinone 2% w/w

3

PHARMACEUTICAL FORM
Topical Cream

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For Topical Administration
For reducing hyperpigmentation of skin, such as persistent freckles and brown marks
(lentigines) and irregular pigmentation of negroid skin.

4.2

Posology and method of administration
Adults and Elderly: Apply twice daily after washing, until pigmentation has been
reduced (depending on skin type, for 6-16 weeks). Then twice weekly.
Children: Not for use on children, unless under the direction of a physician.

4.3

Contraindications
Known hypersensitivity to any of the ingredients.

4.4

Special warnings and precautions for use
Not suitable for red marks.
Do not use on broken skin or near eyes.
For external use only.
Keep medicines away from children.
Discontinue if eczema or irritation occurs, or if darkening reoocurs during treatment.

4.5

Interaction with other medicinal products and other forms of interaction
None known

4.6

Pregnancy and lactation
No undesirable effects known during pregnancy or lactation but contact between
treated skin and infants is to be avoided.

4.7

Effects on ability to drive and use machines
None known

4.8

Undesirable effects
Irritation and subsequent hypersensitivity have been observed but are rare for creams
at less than 5% Hydroquione. Ochronosis and pigmented colloid milium have been
reported following extended use of stronger creams in a high sunshine climate(South
Africa). Such severe effects are preceded by redarkening of the skin and follow
continual administration.

4.9

Overdose
None known as regards topical application. If accidently ingested, treat
symptomatically.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Hydroquinone interferes with the production of new melanocytes and hence the
bleaching effect on pigmented skin progresses slowly and evenly.

5.2

Pharmacokinetic properties
Effects on pigmented skin are normally observed by 6 weeks from initiation of the
hydroquinone treatment. The time varies according to skin type.

5.3

Preclinical safety data
No additional information to that already included elsewhere in the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium lauryl sulphate (Ph. Eur.), propylene glycol (Ph. Eur.), disodium edetate (Ph.
Eur), ascorbic acid (Ph. Eur.), sodium metabisulphite (Ph. Eur.), glyceryl
monostearate (Ph. Eur.), isopropyl myristate (Ph. Eur.), cetyl esters wax (NF),
cetostearyl alcohol (Ph. Eur.), propyl parahydroxybenzoate (Ph. Eur.), potable water.

6.2

Incompatibilities
None

6.3

Shelf life
36 months

6.4

Special precautions for storage
None

6.5

Nature and contents of container
Epoxy-resin lined, collapsible, aluminium tubes with polyethylene closure, containing
50g cream.

6.6

Special precautions for disposal
Wash hands after use

7

MARKETING AUTHORISATION HOLDER
M Sarner (1969) Limited
145-157 St John Street
London
EC1V 4PY

8

MARKETING AUTHORISATION NUMBER(S)
PL 04791/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/06/1984 / 07/02/2001

10

DATE OF REVISION OF THE TEXT
11/10/2006

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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