1. Product Name
Arnican Cream (4% Arnica Extract)
2. Ingredients Per 100 g:
Arnica extract: 4.000 g
3. Dosage Form
Cream
4. Product Information
4.1: Therapeutic IndicationsSymptomatic treatment of ecchymoses.
4.2: Directions for Use and Dosage Gently massage into the skin. Repeat 2 or 3 times per day. Wash hands thoroughly after use.
4.3: Contra-indicationsDo NOT use: – on mucous membranes, the eyes, weeping skin conditions, infected skin lesions or cuts. Do to the presence of terpene-derived excipients, do NOT give to: – children under 30 months; or – children with a history of febrile or non-febrile seizure.
4.4: Precautions and Warnings– Contains terpene-derived excipients. Excessive use on babies and children may cause seizures or similar neurological disorders. Use with caution if you have a history of epilepsy. – Follow the instructions for use carefully and do not exceed the stated dose. – Do not apply to large areas of skin. – Do not apply to the breasts if breast-feeding. – Contains parabens (parahydroxybenzoates). May cause allergic reaction (which may be delayed). Precautions for Use Due to the presence of terpene-derived excipients, use with caution if you are epileptic.
4.5: If you are pregnant or breast-feeding:If you are breast-feeding: Use while breast-feeding is not recommended due to: – the lack of kinetic data regarding the passing of terpene derivatives into breast milk; and – the potential neurological toxicity of terpene derivatives if ingested by babies.
4.6: Possible Side Effects– Allergic reaction necessitating discontinuation of treatment; and – Due to the presence of terpene derivative excipients; or as a result of excessive dose: –– risk of seizures in babies and children; and –– restlessness and confusion in elderly people.
5. Pharmaceutical Information
5.1: ExcipientsArquebuse alcoholate*, ionone, levomenthol, Matricaria essential oil, geranium rosat essential oil, reconstituted neroli essential oil**, lavender essential oil, sodium methylparaben, macrogol oleate (Labrafil® M 1944 CS), emulsifiable ethylene glycol stearate (Monthybase), purified water *Composition: Absinthe, angelica essential oil, basil, Calamintha, sweet fennel, hyssop, lavender, marjoram, lemon balm, peppermint, hypericum, essential oregano oil, rosemary, summer savory essential oil, sage, wild thyme, thyme, ethyl alcohol (96% v/v), purified water **Composition: Reconstituted neroli essential oil, distilled petit grain essential oil, Guinea orange essential oil, methyl anthranilate, rhodinol
5.2: Shelf Life3 years
5.3: Storage InstructionsStore below 25°C.
5.4: PackagingAluminium tube (volume: 15g or 50g) with epoxyphenolic varnish inner coating.
6. Marketing Authorisation
Holder COOPERATION PHARMACEUTIQUE FRANCAISE PLACE LUCIEN-AUVERT 77020 MELUN CEDEX FRANCE
7. Marketing Authorisation
No. * 341 639-1: 50 g tube (coated aluminium)
8. Prescription and Delivery Conditions
Non-prescription medicine
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