Prescribing Information

Flexitol 10% Urea Cream

Manufacturer: Thornton & Ross Ltd, Linthwaite, Huddersfield, HD7 5QH, UK

Code # of Notified Body: N/A

Legal classification: Class I

Product name: Flexitol 10% Urea Cream

Ingredients: Purified Water, Urea, Lanolin, Cetostearyl Alcohol, Glycerine, Dimeticone, Paraffin Oil Light, Glyceryl Monostearate, Decyl Oleate, PEG-20 Stearate, Phenoxyethanol, Sodium PCA, Shea Butter, Panthenol, Tocopheryl Acetate, Benzyl Alcohol, BHT, Perfume.

Indications: Flexitol 10% Urea Cream is intended for the relief of rough, dry and anhidrotic skin conditions.

Adverse reactions: Rarely, allergic reactions such as skin rash, blistering and skin peeling may occur. If you notice these or any other side effects, stop use and speak to your healthcare practitioner, they will tell you what to do.

Precautions: Tubes: Do not use if tube seal is broken or appears tampered with at first use. Pump packs: Do not use if tamper evident collar is broken or missing at first use. All packs: For external use only. Do not use on genitals or other areas of sensitive skin. Do not use on skin that is badly cracked, infected or bleeding. Do not swallow. If accidentally swallowed, seek immediate medical advice and take the pack with you to show which product has been swallowed. Avoid contact with eyes. Treated feet may be slippery. Take extra care when walking on smooth surfaces. Not for use on children under 1 year, except on medical advice. Do not use if sensitive to any of the ingredients. Seek medical advice before use if pregnant or breast feeding. Stop use if skin irritation or rash occurs during use. Do not use at the same time as other skin care products. Fire hazard. Do not smoke or go near naked flames; clothing & bedding with this product dried on them can catch fire easily. Washing clothing and bedding may reduce product build-up but not totally remove it.

Contra-indications: Hypersensitivity to any of the ingredients.

Method of administration: Adults and children over one year. Wash and dry hands before and after use. Apply enough to cover the affected area, one to three times daily or as directed by your healthcare practitioner, smooth gently into the skin.

Date of preparation: 22/03/2021

Flexitol 25% Urea Heel Balm

Manufacturer: Thornton & Ross Ltd, Linthwaite, Huddersfield, HD7 5QH, UK

Code # of Notified Body: CE 2797

Legal classification: Class IIa

Product name: Flexitol Heel Balm

Ingredients: Purified Water, Urea, Lanolin, Cetostearyl Alcohol, Light Liquid Paraffin, Glyceryl Monostearate, Decyl Oleate, PEG-20 Stearate, Paraffin Hard, Phenoxyethanol, Sodium PCA, Shea Butter, Panthenol, Tocopheryl Acetate, Benzyl Alcohol, Perfume.

Indications: Flexitol Heel Balm is intended to be used for the symptomatic treatment of foot anhidrosis, including in consumers with diabetes.

Adverse reactions: Rarely, allergic reactions such as skin rash, blistering and skin peeling may occur. Blackening of treated skin on the sole of the foot may occur very rarely. If you notice these or any other side effects, stop use and speak to your doctor or pharmacist, they will tell you what to do.

Precautions: Tubes: Do not use if tube seal is broken or appears tampered with at first use. Tubs: Do not use if lid seal is broken or appears tampered with at first use.

All packs: For external use only on the heels and feet. Do not swallow. If accidentally swallowed, seek immediate medical advice and take the pack with you to show which product has been swallowed. Avoid contact with eyes. Treated feet may be slippery. Take extra care when walking on smooth surfaces. Stinging may occur in deep cracks. Do not use if sensitive to any of the ingredients. Not for use on children under 12 years, except on medical advice. Seek medical advice before use if pregnant or breastfeeding. Stop use if skin irritation or rash occurs during use.

Contra-indications: Hypersensitivity to any of the ingredients.

Method of administration: Adults and children over 12 years: For use on the heel and foot. Wash and dry hands before and after use. Apply enough to cover the affected area, once or twice daily (for best results twice daily), morning and night or as directed by your healthcare practitioner. Tubes: Use approximately 2cm lengths of balm, rubbing gently into the skin. Always replace cap after each use. Tubs: Use approximately 2g (½ teaspoon) sized amounts, rubbing gently into the skin. Always replace the lid after each use. If no substantial improvement is seen within 14 days, talk to your healthcare practitioner. Once the skin is restored use Flexitol 10% Urea Cream to maintain condition.

Date of preparation: 22/03/2021