Oilatum Plus bath additive

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Triclosan; Liquid paraffin light; Benzalkonium chloride

Available from:

Thornton & Ross Ltd

ATC code:

D02AX

INN (International Name):

Triclosan; Liquid paraffin light; Benzalkonium chloride

Dosage:

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

Pharmaceutical form:

Bath additive

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 13020101; GTIN: 5011091102547 5011091107443

Summary of Product characteristics

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