FLUORIDE 5000 ppm Toothpaste Ref.[9147] Active ingredients: Sodium fluoride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Morningside Healthcare Ltd, 115 Narborough Road, Leicester, LE3 0PA, United Kingdom

Product name and form

Fluoride 5000 ppm Toothpaste.

Pharmaceutical Form

Toothpaste.

For dental use.

Smooth, blue coloured translucent paste with the odour and taste of spearmint.

Qualitative and quantitative composition

1 g of toothpaste contains 5 mg fluoride (as sodium fluoride), corresponding to 5000 ppm fluoride, sodium fluoride 1.1% w/w.

Excipient(s) with known effect:

Sodium benzoate
Sorbitol solution (non-crystallising)
Propylene glycol

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sodium fluoride

Sodium fluoride is indicated for the prevention of dental caries in adolescents and adults, particularly amongst patients at risk from multiple caries (coronal and/or root caries). The primary mode of the caries preventative action of fluoride is post-eruptive, i.e topical action. Systemic fluoride supplements are believed also to act mainly topically (i.e during ingestion, via saliva).

List of Excipients

Sorbitol solution (non-crystallising), E420
Dental type silica (precipitated), E551
Macrogol 600, E1521
Tetrapotassium pyrophosphate, E340
Xanthan gum, E415
Sodium benzoate, E211
Sodium laurilsulphate
Spearmint flavouring (Optamint 948800) containing menthol, propylene glycol, carvone, spearmint oil, peppermint oil, anethol, and vanillin
Saccharin sodium, E954
Brilliant Blue FCF, E133
Purified water

Pack sizes and marketing

Polyethylene/copolymer/aluminium/copolymer/polyethylene laminated tube with a polypropylene flip top closure. 51g.

Marketing authorization holder

Morningside Healthcare Ltd, 115 Narborough Road, Leicester, LE3 0PA, United Kingdom

Marketing authorization dates and numbers

PL 20117/0240

10/12/2014

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