Bepantiseptic First Aid Cream

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Phenol; Chlorhexidine digluconate

Fáanlegur frá:

Bayer Limited

ATC númer:

D08AC; D08AC52

INN (Alþjóðlegt nafn):

Phenol; Chlorhexidine digluconate

Skammtar:

1.2 %w/w/0.25 percent weight/weight

Lyfjaform:

Cream

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

Biguanides and amidines; chlorhexidine, combinations

Leyfisstaða:

Marketed

Leyfisdagur:

1987-01-02

Vara einkenni

Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bepantiseptic First Aid Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenol
1.20
% w/w
Chlorhexidine Digluconate Solution
to give Chlorhexidine Digluconate
0.25
% w/w
Also contains cetostearyl alcohol 10% w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A pink, viscous, homogeneous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of minor skin irritations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply as necessary after cleansing for up to 3 days.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section
6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist or the condition worsens, consult your doctor.
Rare but serious allergic reactions including anaphylaxis have been
reported with use of chlorhexidine containing antiseptic
products. If symptoms of a serious allergic reaction appear (e.g.
wheezing or difficulty breathing, swelling of the face, hives that
can quickly progress to more serious symptoms, severe rash, or shock),
use must be discontinued immediately and doctor
should be consulted.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Chlorhexidine is incompatible with anionic agents.
4.6 FERTILITY, PREGNANCY AND LACTATION
Although use of this product is not contraindicated during pregnancy
and lactation, as with all medicines during pregnancy,
caution should be exercised.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 2 of 4
None known.
4.8 UNDESIRABLE EFFECTS
Spontaneous reports of hypersensitivity reactions (hypersensitivity,
anaphylactic reaction, anaphylactic shock) have been made;
frequency of these reactions cannot be estimated from the available
data.
Rarely irritancy, rashes and other skin conditions may occur.
REPORTING OF SUSPE