It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

DDD Limited

DDD Limited

Summary of Product Characteristics last updated on medicines.ie: 4/2/2014

Blistex Relief Cream

1. NAME OF THE MEDICINAL PRODUCT

Blistex Relief Cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Strong Ammonia Solution

0.27 % w/w

Aromatic Ammonia Solution

6.040 % w/w

Liquefied Phenol

0.494 % w/w

Excipients – Contains Modified Lanolin

25.4 % w/w

For a full list of all excipients, See 6.1

3. PHARMACEUTICAL FORM

Cream

Off white, homogenous, smooth cream with a taste of peppermint.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

The treatment of sore, cracked and chapped lips.

4.2 Posology and method of administration

At first symptoms apply every hour.

By topical application to the lips.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Use on Mucous membranes.

4.4 Special warnings and precautions for use

If the condition persists consult your doctor. If you experience any unwanted effects whilst using Blistex Relief Cream consult your doctor or pharmacist.

Keep all medicines out of the reach and sight of children.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Pregnancy and lactation

Not contra-indicated.

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

Immune system disorders: Hypersensitivity reactions

General disorders: Application site irritation, swelling or inflammation

4.9 Overdose

No known problems associated with overdosage.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The product was developed for topical use and is for the relief of sore, cracked and chapped lips.

Ammonia is incorporated into the formulation for its rubefacient properties.

Phenol is present in the formulation for its disinfectant properties.

Phenol is bacteriostatic in concentrations of about 0.02 % to 1 % bactericidal to some organisms in concentrations as low as 0.4 %. Phenol is also reported to be active against certain viruses.

These two actives are present in an emollient emulsion base, comprising largely of Lanolin 25.4 % w/w and White Petroleum Jelly 33 % w/w. These oleaginous substances, also known as occlusive agents and humectants, are employed as protectives and as agents for softening the skin and rendering it more pliable, but chiefly as vehicles for the more active drugs above.

Emollients soften the skin by forming an occlusive oil film on the stratum corneum, thus preventing drying from evaporation of the water that diffuses to the surface from the underlying layers of skin.

In this way, Blistex Relief Cream provides an effective treatment for sore, cracked and chapped lips.

(References abstracted from Goodman & Gillman and Martindale).

5.2 Pharmacokinetic properties

Approximately 80 mg of Blistex Relief Cream is applied to the lips at any time. Blistex Relief Cream is a topical treatment with locally acting agents.

Any trace quantities of ammonia entering the blood system via Blistex Relief Cream would be so small compared to normal background concentrations of ammonia as to be inconsequential.

Ammonia in the body represents that which is liberated from the deamination of amino acids and the deamination of amides. Portal Venous blood contains a high concentration of ammonia. Normally about 20 % of the urea produced in the body diffuses into the gut, where it is converted by bacteria to ammonia and carbon dioxide. Intestinal bacteria also produces ammonia from dietary proteins. The ammonia is absorbed and converted back to urea in the liver, by way of the Ornithine cycle. Another significant role of ammonia is in the synthesis of glutamine.

Renal excretion - Normal renal venous blood contains a high concentration of ammonia synthesised from glutamine and other amino acids in the kidney. The ammonia that is formed by the kidney is excreted when the urine is acidic, but is largely returned to the systemic circulation if the urine is alkaline. In an acidic urine, NH3 accepts a proton and exists almost entirely as NH4+. Under normal states of metabolism about 70 mEq of non-volatile acid is generated per day: about one half of this is excreted in the urine in conjunction with NH4+, and the remainder is excreted as titratable acid. Renal production of ammonia is stimulated by acidosis: ammonia buffers urinary acid and allows further secretion of protons into the tabular fluid. Potassium depletion also results in a primary increase in the alkalinization of the urine (Tannen, 1977). This may increase the amount of ammonia that is returned to the circulation via the renal vein and have a deleterious effect when potassium depletion coexists with hepatic failure.

Normal physiological mechanisms are designed to keep the concentration of ammonia in the blood as low as possible. Thus, ammonia added to the venous circulation by the kidney or gastrointestinal tract is converted to urea by the liver.

Phenol - A paper published by JAMA in 1953 showed that phenol readily penetrates the human skin and that detoxification by conjugation is initiated immediately.

The pharmaceutical form of Blistex Relief Cream is similar to the aromatised liquid petrolatum of Camphor phenique. This being so, we would expect that after local application the amount of phenol in blood attributable to Blistex Relief Cream would be of the order of 0.0003 mg/100 ml of blood.

According to the Journal of Clinical Pathology 12; 129, 1942 the residual phenol content of blood in normal human beings varies from 0.0 to 0.08 mg/100 ml free phenol and 0.0 to 0.08 mg/100 ml conjugated phenol.

This suggests that residual phenol in normal humans can be anything up to 250 times greater than that which is likely to come from Blistex Relief Cream.

The results of the 1953 paper indicate that phenol from Blistex Relief Cream is rapidly absorbed through the skin and is rapidly detoxified due to its extremely low concentrations.

5.3 Preclinical safety data

N/A

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Saccharin Sodium

Racemic camphor

Polysorbate 40

Peppermint Oil

Sorbitan Palmitate

Ethanol 96 %

Modified Lanolin

White soft paraffin

Cineole

Purified Water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25° C.

6.5 Nature and contents of container

Collapsible printed aluminium tube with elongated nozzle and plastic screw-on cap.

Pack size: 5 g.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

DDD Limited

94, Rickmansworth Road,

Watford,

Hertfordshire, WD18 7JJ

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

PA 302/4/1

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18 January 1994

Date of last renewal: 18 January 2009

10. DATE OF REVISION OF THE TEXT

July 2012

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.