Benzac AC

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Benzoyl peroxide 5%{relative};  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Benzoyl peroxide 5% w/w

Dosage:

5% w/w

Pharmaceutical form:

Topical gel

Composition:

Active: Benzoyl peroxide 5%{relative}   Excipient: Acrylates copolymer Carbomer 940 Colloidal silicon dioxide Disodium edetate dihydrate Docusate sodium Glycerol Poloxamer Propylene glycol Sodium hydroxide Water

Units in package:

Tube, plastic, Sample pack, 5 g

Class:

General sale

Prescription type:

General sale

Manufactured by:

Arkema Inc

Therapeutic indications:

Latest Regulatory Activity

Product summary:

Package - Contents - Shelf Life: Tube, plastic, Sample pack - 5 g - 24 months from date of manufacture stored at or below 25°C - Tube, plastic, - 50 g - 24 months from date of manufacture stored at or below 25°C - Tube, plastic, - 60 g - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1995-05-11

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
BENZAC AC®
BENZOYL PEROXIDE
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about BENZAC AC.
It does not contain all the information available on this medicine. It
does not take the place of talking to
your doctor or pharmacist.
ALL MEDICINES HAVE RISKS AND BENEFITS. IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
If you have any concerns about this medicine, ask your doctor or
pharmacist.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT BENZAC AC IS USED FOR
BENZAC AC Gel is used as an aid for the treatment of acne.
It contains benzoyl peroxide which
• kills the bacteria on the skin that cause acne
• unplugs blocked pores (blackheads and whiteheads)
BENZAC AC Gel also contains acrylates copolymer beads that absorb
excess oils and release glycerol
which reduces the risk of irritation.
BEFORE YOU USE BENZAC AC
_WHEN YOU MUST NOT USE IT _
DO NOT USE BENZAC AC:
• if you have an allergy to any medicine containing benzoyl peroxide
• if you have an allergy to any of the ingredients listed at the end
of this leaflet
Some of the symptoms of an allergic reaction may include:
• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives of the skin
DO NOT USE BENZAC AC IF THE PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT USE BENZAC AC IF THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS
PASSED.
If you use this medicine after the expiry date has passed, it may not
work (as well). If it has expired or is
damaged, return it to your pharmacist for disposal.
IF YOU ARE NOT SURE IF YOU SHOULD START USING BENZAC AC, TALK TO YOUR
DOCTOR OR PHARMACIST.
_BEFORE YOU START TO USE IT _
TELL YOUR DOCTOR OR PHARMACIST IF YOU HAVE ALLERGIES TO ANY OTHER
MEDICINES, FOODS, PRESERVATIVES OR DYES.
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREAST-FEEDING.
BENZAC AC SHOULD ONLY BE USED BY A P

Summary of Product characteristics

NEW ZEALAND DATASHEET
1 PRODUCT NAME
BENZAC
®
AC Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoyl peroxide 25 mg/g, 50mg/g and 100 mg/g
3 PHARMACEUTICAL FORM
BENZAC AC Gel contains benzoyl peroxide 25mg/g or 50mg/g or 100mg/g in
a white to
off-white smooth gel
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an aid in the treatment of mild to moderate acne vulgaris
4.2 Dosage and method of administration
Wash and dry affected areas. Apply the gel in a thin layer to cover
the affected areas once daily,
leaving on the skin for 2 hours then wash off with water. After three
days if no discomfort is
felt, apply in the evening and allow to remain all night. After a
further three days, if there is no
discomfort and the acne is resisting treatment, apply twice a day,
once in the morning. Leave
on all day then wash the affected area and apply again in the evening.
Leave on all night.
Persons with sensitive skin should be directed to apply the gel once
daily before going to bed.
Normal use may cause a mild burning feeling at first followed by some
redness with some
peeling during the first few days.
BENZAC AC Gel is available in three strengths, 2.5%, 5% and 10%.
Unless otherwise directed
begin acne therapy with the weakest strength. This suggestion applies
especially to people
with sensitive skins.
4.3 Contraindications
BENZAC AC Gel is contraindicated in patients with a history of
hypersensitivity to any of its
ingredients.
4.4 Special warnings and precautions for use
For external use only.
A mild burning sensation will probably be felt on first application
and some reddening and
peeling of the skin will occur within a few days. During the first
weeks of treatment a sudden
increase in peeling will occur in most patients. This is not harmful
and will normally subside
within a day or two if treatment is temporarily discontinued.
If severe irritation occurs, patients should be directed to use the
medication less frequently, to
temporarily discontinue use or to discontinue use altogether.
Benzoyl peroxide may cau