BABY GUM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CETALKONIUM CHLORIDE; CHOLINE SALICYLATE

Available from:

RAFA LABORATORIES LTD

ATC code:

N02BA03

Pharmaceutical form:

GEL

Composition:

CETALKONIUM CHLORIDE 0.01 %W/W; CHOLINE SALICYLATE 8.7 %W/W

Administration route:

LOCAL ORAL

Prescription type:

Not required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

Therapeutic group:

CHOLINE SALICYLATE

Therapeutic area:

CHOLINE SALICYLATE

Therapeutic indications:

As an antiseptic and local pain reliever for mouth ulcers, teething pain, denture irritation, and cold sores.

Authorization date:

2020-05-31

Patient Information leaflet

1
PATIENT LEALFET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -1986
This medicine is sold without a doctor's prescription
BABY GUM
®
GEL
ACTIVE INGREDIENTS:
Choline salicylate 8.7% w/w
Cetalkonium chloride
0.01% w/w
For the list of the additional ingredients, see section 6. See also
'Important information about
some of the medicine's ingredients' in section 2.
Read this entire leaflet carefully before using the medicine. This
leaflet contains concise
information about the medicine. If you have any further questions,
please refer to your doctor
or pharmacist.
Use this medicine according to the instructions in the dosage section
in this leaflet. Consult
the pharmacist if you require additional information. If the symptoms
worsen or do not
improve after 3 days, consult your doctor.
1. WHAT IS THE MEDICINE INTENDED FOR?
Antiseptic and pain relieving gel for the mouth.
The medicine is intended for the relief of teething pains, mouth
ulcers, denture irritation and
cold sores.
THERAPEUTIC GROUP:
Choline salicylate – pain reliever
Cetalkonium chloride - antiseptic
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredients or to any of
the additional ingredients the
medicine contains (for a list of the additional ingredients, see
section 6).
•
You are sensitive (allergic) to salicylates, aspirin, non-steroidal
anti-inflammatory drugs
(NSAIDs) or to cetylpyrdinium.
•
You are taking aspirin or other salicylates (unless instructed so by
the doctor).
•
Do not use in infants under 4 months of age.
•
You suffer from an active stomach ulcer, or you have a history of
recurrent stomach ulcer.
•
Do not use in cases of viral illnesses, such as influenza or
chickenpox, particularly in children
and adolescents under 16 years of age for fear of Reye’s syndrome.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
•
If there is no improvement after 3 days, consult your doctor.
•
Do not use this medicine frequently or for a long period without
consul

Summary of Product characteristics

Baby Gum-DL-Nov 2023-02
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Baby Gum Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
Choline salicylate
8.7%
Cetalkonium chloride 0.01%
EXCIPIENT
Ethanol
38% w/w
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Clear, colorless oromucosal gel.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an antiseptic and local pain reliever for mouth ulcers, teething
pain, denture irritation, and cold
sores.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
By topical application to the oral mucosa.
Adults: Using a clean finger, massage approximately 1-1.5 cm of the
gel onto the sore area, not more
than once every 3-4 hours.
Do not apply more than six doses in any 24 hour period.
Children (from four months to 16 years old): Using a clean finger,
massage approximately 0.5 cm (a
pea size amount) of gel onto the sore area, not more than once every
3-4 hours. Do not apply more than
six doses in any 24 hour period. Not suitable for infants under four
months.
Do not exceed the stated dose.
If symptoms do not improve after 3 days seek medical advice (see
section 4.4).
Older people:
There is no indication that dosage need be modified in the elderly.
4.3
CONTRAINDICATIONS
Not to be used in infants under four months.
Hypersensitivity to choline salicylate, cetalkonium chloride or to any
of the excipients in the product
listed in section 6.1.
Not to be used in patients with hypersensitivity to salicylates,
aspirin or other NSAIDs, to
cetylpyrdinium or to any of the excipients.
2
Not to be used in patients with active or a history of recurrent
peptic ulceration.
Do not use in patients currently suffering from viral illnesses such
as varicella (chicken pox) or
influenza infection particularly in children and adolescents under 16
years of age due to the risk of
precipitating Reye’s syndrome in this patient populatio
n.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The recommended dose and frequency should not be exceeded especially
in child