Colgate Duraphat® 2800 ppm Fluoride Toothpaste – Name of the medicinal product: Duraphat® 2800 ppm Fluoride Toothpaste. Active ingredient: Sodium Fluoride 0.619 %w/w (2800 ppm F-). Indications: For the prevention and treatment of dental caries (coronal and root) in adults and children 10 years of age and over. Dosage and administration: Use daily instead of normal toothpaste. Apply a 1cm line of paste across the head of a toothbrush and brush the teeth thoroughly for one minute morning and evening. Spit out after use; for best results do not drink or rinse for 30 minutes. Contraindications: Individuals with known sensitivities should consult their dentist before using. Not to be used in children under 10 years old. Special warnings and precautions for use: Not to be swallowed. Undesirable effects: When used as recommended there are no side effects. Legal classification: POM. Marketing authorisation number: PL00049/0039. Marketing authorisation holder: Colgate-Palmolive (U.K.) Ltd. Guildford Business Park, Midleton Road, Guildford, Surrey, GU2 8JZ. Recommended retail price: £5.10 (75ml tube). Date of revision of text: January 2015.
Colgate® Duraphat® 5000 ppm Fluoride Toothpaste – Name of the medicinal product: Duraphat® 5000 ppm Fluoride Toothpaste. Active ingredient: Sodium Fluoride 1.1%w/w (5000ppm F-). 1g of toothpaste contains 5mg fluoride (as sodium fluoride), corresponding to 5000ppm fluoride. Indications: For the prevention of dental caries in adolescents and adults 16 years of age and over, particularly amongst patients at risk from multiple caries (coronal and/or root caries). Dosage and administration: Brush carefully on a daily basis applying a 2cm ribbon onto the toothbrush for each brushing. 3 times daily, after each meal. Contraindications: This medicinal product must not be used in cases of hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: An increased number of potential fluoride sources may lead to fluorosis. Before using fluoride medicines such as Duraphat, an assessment of overall fluoride intake (i.e. drinking water, fluoridated salt, other fluoride medicines – tablets, drops, gum or toothpaste) should be done. Fluoride tablets, drops, chewing gum, gels or varnishes and fluoridated water or salt should be avoided during use of Duraphat Toothpaste. When carrying out overall calculations of the recommended fluoride ion intake, which is 0.05mg/kg per day from all sources, not exceeding 1mg per day, allowance must be made for possible ingestion of toothpaste (each tube of Duraphat 500mg/100g Toothpaste contains 255mg of fluoride ions). This product contains Sodium Benzoate. Sodium Benzoate is a mild irritant to the skin, eyes and mucous membrane. Undesirable effects: Gastrointestinal disorders: Frequency not known (cannot be estimated from the available data): Burning oral sensation. Immune system disorders: Rare (≥1/10,000 to <1/1,000): Hypersensitivity reactions. Legal classification: POM. Marketing authorisation number: PL00049/0050. Marketing authorisation holder: Colgate-Palmolive (U.K.) Ltd. Guildford Business Park, Midleton Road, Guildford, Surrey, GU2 8JZ. Recommended retail price: £7.99 (51g tube). Date of revision of text: February 2015.