INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo KIDDIGUM teething powder

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

KIDDIGUM teething powder

COMPOSITION:
Each 0,75 g (one capful) contains Benzocaine 0,0195 g (2,6% m/m).

PHARMACOLOGICAL CLASSIFICATION:
4 (local anaesthetics).

PHARMACOLOGICAL ACTION:
Benzocaine is a surface anaesthetic of the ester type i.e. chemically it is an ester of p-ammo-benzoic acid. It is poorly soluble in water and consequently too slowly absorbed to be toxic. Thus benzocaine remains localized for a long period of time which accounts for its sustained anaesthetic action. The anaesthetic effect is almost entirely on nerve terminals. (Ref. Goodman & Gillman 6th Edition; Martindale 27th Edition; U.S.D. 25th Edition).

INDICATIONS:
Sore, irritated gums in infants, due to teething or minor ulceration.

CONTRA-INDICATIONS:
Contra-indicated in patients being treated with sulphonamides or suffering with hypoxemia.

WARNINGS:
Benzocaine may cause methaemoglobinaemia, but this is rarely serious unless the patient is already hypoxic.

DOSAGE AND DIRECTIONS FOR USE:
Gently rub half to one capful of vial (up to 0,75 g) into baby's gums every 3 hours if necessary. Use only when required.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Very rarely a contact dermatitis may cause redness. In this case use of the product should be discontinued immediately.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The main systemic toxic effect is excitation of the C.N.S. manifested by yawning, restlessness, excitement, nervousness, nausea, vomiting, muscle twitching and convulsions. (This may be transient followed by depression with drowsiness, respiratory failure and coma).

In the case of overdosage the patient should be taken to a doctor or hospital immediately.

CONDITIONS OF REGISTRATION:

IDENTIFICATION:
A pale pink powder with raspberry flavour and a numbing effect on mucous membrane.

PRESENTATION:
A glass vial with polythene measure-cap.

STORAGE INSTRUCTIONS:
Keep out of reach of children. Store in a dry place below 30°C out of direct sunlight.

APPLICATION NUMBER:
G2817 (Wet/Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Adco Drug Co. (Pty) Ltd
491 Sydney Road
DURBAN 4001

DATE OF PUBLICATION OF PACKING INSERT:

LEA 611/01.95        Proprint

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