Calamine Lotion, cutaneous suspension

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Zinc oxide; Calamine

Sẵn có từ:

Ovelle Limited

Mã ATC:

D02AB

INN (Tên quốc tế):

Zinc oxide; Calamine

Liều dùng:

15 %w/v + 5 percent weight/volume

Dạng dược phẩm:

Cutaneous suspension

Loại thuốc theo toa:

Product not subject to medical prescription

Khu trị liệu:

Zinc products

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

1992-10-14

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calamine Lotion, cutaneous suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calamine 15% w/v
Zine Oxide 5% w/v
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous Suspension.
Calamine Lotion is a pale pink lotion which separates on standing.
It has a faint characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calamine Lotion is a mild astringent lotion recommended for the
topical treatment of mild skin irritation and
inflammation, including mild sunburn.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Calamine Lotion is applied topically to the affected area with cotton
wool and allowed to dry.
4.3 CONTRAINDICATIONS
Calamine Lotion is contraindicated in patients with a known
sensitivity to its ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
No adverse effects reported.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Zinc oxide is incompatible with benzylpenicillin. Zinc oxide reacts
slowly with fatty acid in oils and fats to produce the
corresponding fatty acid esters.
4.6 FERTILITY, PREGNANCY AND LACTATION
No adverse effects reported.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No adverse effects reported.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_4_
_/_
_0_
_9_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_8_
_9_
_6_
_1_
_9_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.8 UNDESIRABLE EFFECTS
None reporte