LACTICARE Cutaneous Emulsion 2.5/5.0 %w/w

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

SODIUM PYRROLIDONE CARBOXYLATE LACTIC ACID

Dostopno od:

Stiefel Laboratories (U.K.) Ltd.

Odmerek:

2.5/5.0 %w/w

Farmacevtska oblika:

Cutaneous Emulsion

Datum dovoljenje:

1977-06-23

Lastnosti izdelka

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
LactiCare
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Cutaneous emulsion.
A white viscous lotion.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
LactiCare is indicated
for the symptomatic relief of hyperkeratotic and
other chronic dry skin conditions.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
LactiCare can be used as often as required. Apply to
the affected skin and rub in gently.
4.3 CONTRAINDICATIONS
None known.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Keep away from the eyes and mucous membranes. Should
contact with the eyes occur, remove with water.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
None known.
4.6 PREGNANCY AND LACTATION
There are no restrictions on the use of LactiCare in pregnancy
and lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
Sodium Pyrrolidone Carboxylate
2.5 % w/w
Lactic Acid
5.0 % w/w
For excipients, see 6.1
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 30/11/2005_
_CRN 2017329_
_page number: 1_
4.8 UNDESIRABLE EFFECTS
Occasionally a transient mild stinging sensation may occur. Should
prolonged irritation develop when used on abraded 
or inflamed skin, discontinue use.
4.9 OVERDOSE
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
LactiCare contains both
the humectant sodium pyrrolidone carboxylate and lactic acid
formulated in an oil in water 
emulsion base to promote hydration
5.2 PHARMACOKINETIC PROPERTIES
Not applicable; the product is for cutaneous use and
acts locally at the site of application.
5.3 PRECLINICAL SAFETY DATA
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Carbomer 940
Imidurea
Dehydroacetic Acid
Sodium