Acnecide 5% w/w Gel

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Benzoyl Peroxide

Հասանելի է:

Lexon Pharmaceuticals (Ireland) Limited

ATC կոդը:

D10AE; D10AE01

INN (Միջազգային անվանումը):

Benzoyl Peroxide

Դեղագործական ձեւ:

Gel

Թերապեւտիկ տարածք:

Peroxides; benzoyl peroxide

Հաստատման ամսաթիվը:

2022-10-28

Տեղեկատվական թերթիկ

ACNECIDE
5% W/W GEL
TUBE LABEL:
SIZE 75MM X 75MM
SELF ADHESIVE BACKED
PRINTED IN ONE COLOUR: BLACK
®
Scan of source country tube
Position of label on source country tube
A
CNECIDE 5% W/W GEL
30G
benzoyl peroxide
CONTAINS: Hydrous Benzoyl Peroxide equivalent to Benzoyl
peroxide 5% w/w, carbomer, sodium edetate, poloxamer,
docusate sodium, silicon dioxide, propylene glycol, glycerol,
methacrylate copolymer, sodium hydroxide solution and purified
water.
FOR THE TREATMENT OF ACNE
LEAVE-ON DAILY TREATMENT FOR ACNE. Unblocks pores,
blackheads and whiteheads.
PLEASE READ THE ENCLOSED LEAFLET BEFORE USE.
DO NOT STORE ABOVE 25°C. DO NOT FREEZE.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
DIRECTIONS: After washing with a mild cleanser and water,
apply ACNECIDE once or twice a day to the entire affected
areas, or as directed by your doctor or pharmacist. People with
sensitive skin should apply the gel once daily before bedtime.
Read the package leaflet before use.
MAY BLEACH HAIR AND DYED FABRICS.
WARNING: AVOID CONTACT WITH THE EYES, EYELIDS,
LIPS AND OTHER DELICATE AREAS OF THE SKIN. AVOID
REPEATED EXPOSURE TO SUNLIGHT OR UV RADIATION
WHILE USING.
BN: EXP:
RN:
FOR EXTERNAL USE ONLY
®
PPA Holder: Lexon Pharmaceuticals (Ireland) Limited.
PPA23176/054/001
Ref:23176/054/001/TL230922/1
A
CNECIDE 5% W/W GEL
30G
benzoyl peroxide
CONTAINS: Hydrous Benzoyl Peroxide equivalent to Benzoyl
peroxide 5% w/w, carbomer, sodium edetate, poloxamer,
docusate sodium, silicon dioxide, propylene glycol, glycerol,
methacrylate copolymer, sodium hydroxide solution and purified
water.
FOR THE TREATMENT OF ACNE
LEAVE-ON DAILY TREATMENT FOR ACNE. Unblocks pores,
blackheads and whiteheads.
PLEASE READ THE ENCLOSED LEAFLET BEFORE USE.
DO NOT STORE ABOVE 25°C. DO NOT FREEZE.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
DIRECTIONS: After washing with a mild cleanser and water,
apply ACNECIDE once or twice a day to the entire affected
areas, or as directed by your doctor or pharmacist. People with
sensitive skin should apply the gel once daily befo

Ապրանքի հատկությունները

Health Products Regulatory Authority
28 October 2022
CRN00D3MN
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acnecide 5% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrous benzoyl peroxide equivalent to benzoyl peroxide 5 % w/w.
Excipient(s) with known effect:
One gram of gel contains 40 mg of propylene glycol (E1520)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
_Product imported from Austria_
White to off-white, smooth gel.
4 CLINICAL PARTICULARS
As per PA22743/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA22743/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Docusate sodium
sodium edetate
Poloxamer
Carbomer
Propylene glycol
methacrylate copolymer
Glycerol
Silicon dioxide
Purified Water
Sodium hydroxide to adjust the Ph
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the tube and outer package of the product on the market
in the country of origin.
Shelf life after opening: 6 months
Health Products Regulatory Authority
28 October 2022
CRN00D3MN
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
White low density polyethylene tubes with white polypropylene screw
caps. Pack size 60 g (2 x 30 g)
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited,
Block 3,
Harcourt Centre,
Harcourt Road,
Dublin 2,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/054/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28
th
October 2022
10 DATE OF REVISION OF THE TEXT