Boots Bite and Sting Relief Liquid

1. Name Of The Medicinal Product

After Bite, Boots Bite and Sting Relief Liquid.

2. Qualitative And Quantitative Composition

After Bite contains Strong Ammonia Solution BP corresponding to 3.5% w/v ammonia.

3. Pharmaceutical Form

Topical emulsion for cutaneous application.

4. Clinical Particulars

4.1 Therapeutic Indications

Relief from insect bites, including mosquitoes, horse flies, and relief from stings including wasps, bees, jellyfish and nettles.

4.2 Posology And Method Of Administration

Cutaneous administration.

For adults and children over 2 years old

Apply as required. Rub applicator on affected area. Prompt use gives maximum relief. If itching persists repeat the application. Do not bandage or cover tightly until dry.

Daub After Bite directly on the bite or sting. Apply promptly to the bite for best results. If itching persists or recurs, repeat application. Replace cap after each use.

4.3 Contraindications

After Bite is contraindicated in individuals with known hypersensitivity to ammonia.

4.4 Special Warnings And Precautions For Use

Keep out of reach of children. For external use only. If swallowed do not induce vomiting. Drink milk and citrus juices and consult a doctor.

If rash, redness, irritation, swelling or pain increases or worsen after application, discontinue use and seek medical advice.

Avoid mouth or eyes. If this should occur rinse well with water.

The insect bite should be left exposed to the air for a brief period of time after application to aid in evaporation of ammonia.

The label shall state: Contains strong ammonia solution.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

None known for the use of topical ammonia solution.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Frequency not known: rash, redness, irritation, swelling or pain may increase following application of this product (see section 4.4).

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Strong ammonia solution is known to have the property of a counter-irritant.

5.2 Pharmacokinetic Properties

There are no relevant pharmacokinetics for strong ammonia solution used as a counter-irritant.

5.3 Preclinical Safety Data

After Bite contains strong ammonia solution which is a known counter irritant. Specific toxicology studies have not been conducted to demonstrate the safety of this product.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Mineral oil

Alcohol ethoxylate

Dimethylpolysiloxane

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25^o C.

6.5 Nature And Contents Of Container

High density polyethylene vial having a low density polyethylene friction fit applicator tip with a screw cap moulded of polypropylene with a fill capacity of 14.8 ml and filled to contain 14 ml.

6.6 Special Precautions For Disposal And Other Handling

No special instructions. See Section 4.4.

7. Marketing Authorisation Holder

Tender Limited

Netqubate Business Centre

72-73 Bartholomew Street

Newbury

Berkshire

RG14 5DU

8. Marketing Authorisation Number(S)

PL 15536/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

11 November 1998 / 11 November 2003

10. Date Of Revision Of The Text

8 June 2009.

11 DOSIMETRY (IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)