Oilatum Plus bath additive

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

现在购买

下载 资料单张 (PIL)
07-06-2018
下载 产品特点 (SPC)
07-06-2018

有效成分:

Triclosan; Liquid paraffin light; Benzalkonium chloride

可用日期:

Thornton & Ross Ltd

ATC代码:

D02AX

INN(国际名称):

Triclosan; Liquid paraffin light; Benzalkonium chloride

剂量:

20mg/1gram ; 525mg/1gram ; 60mg/1gram

药物剂型:

Bath additive

给药途径:

Cutaneous

类:

No Controlled Drug Status

处方类型:

Never Valid To Prescribe As A VMP

產品總結:

BNF: 13020101; GTIN: 5011091102547 5011091107443

产品特点

                                OBJECT 1
OILATUM PLUS
Summary of Product Characteristics Updated 23-Dec-2016 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Oilatum Plus
Oilatum Junior Flare-Up
2. Qualitative and quantitative composition
Light liquid paraffin 52.5% w/w, benzalkonium chloride 50% solution
12.0% w/w*, triclosan 2% w/w
*equivalent to 6% benzalkonium chloride
3. Pharmaceutical form
Bath additive
4. Clinical particulars
4.1 Therapeutic indications
Topical as a bath additive.
For the prophylactic treatment of eczemas at risk from infection.
4.2 Posology and method of administration
For cutaneous use only.
Oilatum Plus must always be used diluted in water. It is an effective
cleanser and should not be used with
soap.
Use once daily. Do not exceed the recommended dose:
ADULTS, ADOLESCENTS AND CHILDREN:In an eight inch bath (20 cm) add 2
capfuls (20 ml); in a four inch (10
cm) bath add 1 capful (10 ml). Mix well.
Soak for 10-15 minutes. Gently pat the skin dry with a clean towel.
INFANTS OVER 6 MONTHS OF AGE: Add 1 ml (just sufficient to cover the
bottom of the cap) to a baby bath
containing approximately 15 litres of water and mix well. Soak for
10-15 minutes. Gently pat the skin dry
with a clean towel.
The safety and efficacy of Oilatum Plus has not been established in
children less than 6 months of age.
Oilatum Plus is not recommended for use in children under 6 months of
age.
ELDERLY: No dosage adjustment is required in the elderly.
4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1
4.4 Special warnings and precautions for use
Oilatum Plus contains benzalkonium chloride which is irritant and may
cause skin reactions.
Keep out of reach and sight of children.
If irritation or rash occurs when the product is used in the correct
dilution, use should be discontinued.
If the undiluted product comes into contact with the eye, reddening
may occur. The patient should be
advised to perform eye irrigation for 15 minutes. If there is
persistent irritation th
                                
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