BLISTEX RELIEF CREAM – Summary of Product Characteristics (SmPC)

This data is meant to be used by well being professionals

Robust ammonia answer

0.100% w/w

Fragrant ammonia answer

6.040% w/w

Liquefied phenol

0.494% w/w

For excipients, see 6.1.

Cream.

Off white clean cream.

For fast aid of occasional chilly sores, cracked lips or chapped lips.

At first signs apply each hour. By topical software to the lips.

Hypersensitivity to the energetic substances or to any of the excipients.

Should you endure from recurrent chilly sores seek the advice of your physician.

Immune system issues: Hypersensitivity reactions

Basic issues: Utility website irritation, swelling or irritation

Reporting of suspected hostile reactions

Reporting suspected hostile reactions after authorisation of the medicinal product is vital. It permits continued monitoring of the profit/threat stability of the medicinal product. Healthcare professionals are requested to report any suspected hostile reactions through the Yellow Card Scheme, web site: www.mhra.gov.uk/yellowcard.

No recognized issues related to overdosage.

Pharmacotherapeutic group: Different dermatologicals ATC code: D11 AX

The product was developed for topical use and is for the aid of occasional chilly sores, cracked lips and chapped lips.

Ammonia is integrated into the formulation for its rubefacient properties.

Phenol is current within the formulation for its disinfectant properties. Phenol is bacteriostatic in concentrations of about 0.02% to 1% bactericidal to some organisms in concentrations as little as 0.4%. Phenol can be reported to be energetic in opposition to sure viruses.

These two actives are current in an emollient emulsion base, comprising largely of lanolin 25.4% w/w and White Smooth Paraffin 33% w/w. These oleaginous substances, often known as occlusive brokers and humectants, are employed as protectives and as brokers for softening the pores and skin and rendering it extra pliable, however mainly as autos for the extra energetic medication above.

Emollients soften the pores and skin by forming an occlusive oil movie on the stratum corneum, thus stopping drying from evaporation of the water that diffuses to the floor from the underlying layers of pores and skin.

On this approach, Blistex Reduction Cream gives an efficient remedy for the aid of occasional chilly sores, cracked lips and chapped lips.

(References abstracted from Goodman & Gillman and Martindale).

Roughly 80mg of Blistex Reduction Cream is utilized to the lips at anybody time. Blistex Reduction Cream is a topical remedy with domestically performing brokers.

Any hint portions of ammonia getting into the blood system through Blistex Reduction Cream could be so small in comparison with regular background concentrations of ammonia as to be inconsequential.

Ammonia within the physique represents that which is liberated from the deamination of amino acids and the deamination of amides. Portal venous blood comprises a excessive focus of ammonia. Usually about 20% of the urea produced within the physique diffuses into the intestine, the place it’s transformed by micro organism to ammonia and carbon dioxide. Intestinal micro organism additionally produce ammonia from dietary proteins. The ammonia is absorbed and transformed again to urea within the liver, by the use of the ornithine cycle. One other important function of ammonia is within the synthesis of glutamine.

Renal excretion – Regular renal venous blood comprises a excessive focus of ammonia synthesised from glutamine and different amino acids within the kidney. The ammonia that’s fashioned by the kidney is excreted when the urine is acidic, however is essentially returned to the systemic circulation if the urine is alkaline. In an acidic urine, NH3 accepts a proton and exists virtually solely as NH4+. Underneath regular states of metabolism about 70mEq of non-volatile acid is generated per day: about one half of that is excreted within the urine along with NH4+, and the rest is excreted as titratable acid. Renal manufacturing of ammonia is stimulated by acidosis: ammonia buffers urinary acid and permits additional secretion of protons into the tabular fluid. Potassium depletion additionally leads to a main enhance within the alkalinization of the urine (Tannen, 1977). This will enhance the quantity of ammonia that’s returned to the circulation through the renal vein and have a deleterious impact when potassium depletion coexists with hepatic failure.

Regular physiological mechanisms are designed to maintain the focus of ammonia within the blood as little as attainable. Thus, ammonia added to the venous circulation by the kidney or gastrointestinal tract is transformed to urea by the liver.

Phenol – A paper revealed by JAMA in 1953 confirmed that phenol readily penetrates the human pores and skin and that cleansing by conjugation is initiated instantly.

The pharmaceutical type of Blistex Reduction Cream is much like the aromatised liquid petrolatum of Camphor phenique. This being so, we’d anticipate that after native software the quantity of phenol in blood attributable to Blistex Reduction Cream could be of the order of 0.0003 mg/100ml of blood.

In accordance with the Journal of Scientific Pathology 12:129, 1942 the residual phenol content material of blood in regular human beings varies from 0.Zero to 0.08 mg/100ml free phenol and 0.Zero to 0.08 mg/100ml conjugated phenol.

This means that residual phenol in regular people could be something as much as 250 instances larger than that which is prone to come from Blistex Reduction Cream.

The outcomes of the 1953 paper point out that phenol from Blistex Reduction Cream is quickly absorbed by means of the pores and skin and is quickly detoxified as a consequence of its extraordinarily low concentrations.

White gentle paraffin

Purified water

Modified lanolin

Sorbitan palmitate

Peppermint oil

Polysorbate 40

Ethanol 96%

Cineole

Racemic camphor

Saccharin sodium

Don’t retailer above 25°C.

Hold all medicines out of the attain of youngsters.

Collapsible printed aluminium tube with elongated nozzle and plastic screw-on cap, containing 3.5 g or 5 g of cream.

Not all pack sizes could also be marketed.

No particular necessities

Administration Particulars

DDD restricted

94 Rickmansworth Street

Watford

Hertfordshire

United Kingdom. WD18 7JJ

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