Boots Teething Gel 3 Months +

1. Name Of The Medicinal Product

Boots Teething Gel 3 Months Plus or Children's Teething Gel or Infant Sugar Free Teething Gel or Children's 3 Months Plus Teething Gel or Children's 3 Months Plus Teething Gel Sugar Free or Boots Sugar Free Teething Gel 3 Months Plus.

2. Qualitative And Quantitative Composition

Active ingredient	Quantity
Lignocaine Hydrochloride Ph Eur	0.6% w/w
Cetylpyridinium Chloride Ph Eur	0.02% w/w

3. Pharmaceutical Form

Gel

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of teething troubles.

4.2 Posology And Method Of Administration

Children over 3 months:

Apply a small quantity of gel to the sore area. Repeat the application every

three hours if necessary.

For topical application to mouth and gums.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no clinically significant interactions.

4.6 Pregnancy And Lactation

The safety of this medicine during pregnancy and lactation has not been established, but use during these periods is not considered to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Hypersensitivity reactions due to lignocaine have been reported rarely and to cetylpyridinium chloride occasionally.

4.9 Overdose

Overdosage with this medicine is unlikely to constitute a hazard and therefore symptomatic treatment only is necessary.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Lignocaine is a local anaesthetic of the amide type. Cetylpyridinium Chloride is a cationic antiseptic.

5.2 Pharmacokinetic Properties

Lignocaine is readily absorbed from mucous membranes. The plasma elimination half life is about two hours. Lignocaine is bound to plasma proteins, including α-1 acid glycoprotein. Extent of binding is between 60 and 80%.

Lignocaine undergoes significant first pass metabolism in the liver and is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed to various metabolites including glycinexylidide. Less than 10% is excreted unchanged by the kidneys. The metabolites are also excreted in the urine.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Methocel E4 Premium

Glycerin

Sodium saccharin crystals

Citric acid monohydrate

Sorbic acid

Sodium citrate

Salt pure vacuum dried extra analysis

Spearmint Naefco flav Firmench

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

An internally lacquered collapsible aluminium tube with a membrane seal and

either a polyethylene or polypropylene white wadless screw cap with a piercer

device.

Pack sizes: 13/15 gm

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/0392

9. Date Of First Authorisation/Renewal Of The Authorisation

12 March 1990 / 15 May 2000

10. Date Of Revision Of The Text

November 2003