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

Logo BACTIZIP (Topical spray)

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

BACTIZIP (Topical spray)

COMPOSITION:
BACTIZIP
contains:

Chlorhexidine gluconate 20% 0.075 % v/v
Cetrimide         0.15% m/v
Ethanol         7.0% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 13.1 Antiseptics, disinfectant and cleansing agents.

PHARMACOLOGICAL ACTION:
Chlorhexidine and cetrimide combination has antiseptic, detergent and cleansing properties.
It has antibacterial properties.
Chlorhexidine is poorly absorbed from the gastrointestinal tract.

INDICATIONS:
BACTIZIP
is used for antiseptic and cleansing purposes.

CONTRA-INDICATIONS:
Hypersensitivity to chlorhexidine gluconate and cetrimide.
Do not use in body cavities, in the middle ear, in the eye, on mucous membranes, on the brain, meninges, and during neurosurgery.
Paediatrics –safety and efficacy in children have not been established.

WARNINGS:
For external use only.
Prolonged and repeated applications may cause hypersensitivity.
Wet dressings should not be left in contact with skin as sensitivity may occur.
Avoid contact with the eyes.
Do not use to disinfect soft contact lenses (it may be adsorbed and cause irritation).

INTERACTIONS:
Soaps, blood, cotton, cellulose and other organic matter will reduce the effectiveness of BACTIZIP. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with BACTIZIP. Oxidizing bleach, such as sodium perborate, should be used in laundering.
BACTIZIP is incompatible with anionic agents.

PREGNANCY AND LACTATION:
Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
For external use only.
No dilution necessary.
For minor cuts, abrasions, stings and insect bites –spray on the affected area.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Skin and subcutaneous tissue disorders
:
Less frequent: Skin irritation.
See “Contra-indications” and “Warnings”.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.
Accidental ingestion may cause nausea and vomiting, dyspnoea and cyanosis due to paralysis of the respiratory muscles, possibly leading to asphyxia. Depression of the central nervous system with convulsions, hypertension and coma may occur.
Specialised treatment is essential as soon as possible, thus, consult a medical practitioner, or take the patient to the nearest hospital immediately. Gastric lavage with demulcents is suggested following acute ingestion.

IDENTIFICATION:
A clear, yellow, particle-free solution.

PRESENTATION:
500 mL transparent plastic bottle with white plastic cap or 100 mL green opaque plastic bottle with white spray nozzle with clear protective cap.

STORAGE INSTRUCTIONS:
Store below 25ºC. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
A38/13.1/0472

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
CIPLA-MEDPRO (PTY) LTD
Rosen Heights
Pasita Street
Rosen Park
Bellville
7530
RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 April 2010

CM104A/SA

New addition to this site: January 2017
Source: Pharmaceutical Industry
http://www.cipla.co.za/wp-content/uploads/2013/10/otc_bactizip-topical-spray.pdf

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