Para Special Lice solution for cutaneous spray in pressurised bottle

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

PIPERONYL BUTOXIDE, DEPALLETHRINE

Fáanlegur frá:

Laboratoires Omega Pharma France 2 rue Chaintron, BP 850, 92542 Montrouge, France

ATC númer:

P03AC52

INN (Alþjóðlegt nafn):

PIPERONYL BUTOXIDE 7.2 % (W/W) DEPALLETHRINE 1.8 % (W/W)

Lyfjaform:

CUTANEOUS SPRAY, SOLUTION

Samsetning:

PIPERONYL BUTOXIDE 7.2 % (W/W) DEPALLETHRINE 1.8 % (W/W)

Gerð lyfseðils:

OTC

Lækningarsvæði:

ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS

Leyfisstaða:

Withdrawn

Leyfisdagur:

2007-04-12

Upplýsingar fylgiseðill

Vara einkenni

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME 

PARA SPECIAL LICE, solution for cutaneous spray in pressurised
bottle. 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

Depallethrine ................................................................................................................1.800
g 
Piperonyl
butoxide .......................................................................................................7.200 g 

Isododecane ..................................................................................................................90.00
g 
Propellant gas 
1-1-1-2-tetrafluoroethane
(HFA 134A)......................................................................100.00
g 

per 100 g of solution. 

3.  PHARMACEUTICAL FORM 

Solution for cutaneous spray in pressurised bottle. 

4.  CLINICAL DATA 

4.1  Therapeutic Indications 

Treatment of pediculosis of the scalp (head lice). 

4.2  Dosage and Administration 

EXTERNAL USE 

The lotion should be applied onto the scalp and the
dry hair in A VENTILATED PLACE, and AWAY 
FROM ANY FLAME OR INCANDESCENT OBJECT. 
Do not smoke. 

-  Be careful to protect the eyes, nose and mouth with
a towel. 
-  Spray by pressing for one second by placing the end of
the spray tube at about 3 cm from 
the hair. Take care to separate carefully the locks of hair
so that the hair are completely 
soaked. 

-  Allow the hair to dry naturally in the air. DO
NOT USE HAIR DRIER due to the risk of 
INFLAMMATION. 

Allow the product to act for 30 minutes, then wash the hair
with a gentle shampooing that 
makes removal of the dead nits easier. 
Page 2 of 4 

-  The hair is then combed with a fine comb. 

Due to the _flammability_ of the product: 

∗  do not use any artificial heat source
such as an hair drier; 
∗  do not use near a flame or any incandesc