Oilatum cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Liquid paraffin light; White soft paraffin

Available from:

Thornton & Ross Ltd

INN (International Name):

Liquid paraffin light; White soft paraffin

Dosage:

60mg/1gram ; 150mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13020100; GTIN: 5011091100390 5011091102950 5011091102974 5011091105739 5000123113934

Patient Information leaflet

DIRECTIONS
Apply to the affected area. Use as
often as required or as directed by
your pharmacist or doctor.
OILATUM
® JUNIOR CREAM is especially
effective if applied immediately
after washing, to counteract the
loss of essential
oils from the skin.
OILATUM
® JUNIOR CREAM is suitable
for children and babies.
MARKETING AUTHORISATION HOLDER
AND MANUFACTURER:
Thornton & Ross Ltd., Huddersfield,
HD7 5QH, UK.
PL 00240/0467
Date of information: September 2020
ACTIVE INGREDIENTS
light liquid paraffin 6.0% w/w,
white soft paraffin 15.0% w/w.
OTHER INGREDIENTS:
Macrogol
1000 Monostearate,
Cetostearyl
Alcohol*,
Glycerol, Potassium Sorbate*,
Benzyl
Alcohol
(0.5%w/w)*,
Citric Acid Monohydrate,
Povidone, Purified Water.
*May cause allergic/local
skin
reactions or irritation (e.g.
contact dermatitis).
Do not use the product after
the expiry date.
Store below 25ºC.
150 G
OILATUM
® JUNIOR CREAM
is an emollient (softening,
soothing agent) and has been
specially developed for children
and babies. It is used in the
treatment of eczema and related
dry skin conditions. OILATUM
®
JUNIOR CREAM forms a protective
film which moisturises, soothes,
softens and rehydrates the skin. It
is especially effective after
washing. It is suitable for people
allergic to lanolin.
Fragrance free
SOOTHES, SOFTENS AND REHYDRATES
RELIEVES ITCHING
SUITABLE FOR BABIES AND CHILDREN
JUNIOR CREAM
NEW SAFETY INFORMATION – SEE LABEL
92961212009
FOR ECZEMA AND RELATED
DRY SKIN CONDITIONS
JUNIOR CREAM
Cream
light liquid paraffin
white soft paraffin
FIRE HAZARD. DO NOT SMOKE OR GO
NEAR NAKED FLAMES; CLOTHING &
BEDDING WITH THIS PRODUCT DRIED
ON THEM CAN CATCH FIRE EASILY.
WARNINGS
Avoid using the product if you are
sensitive to any of the ingredients.
If an adult uses this product whilst
breast-feeding, wash all
traces
prior to feeding.
Do not smoke or go near naked
flames - risk of severe burns. Fabric
(clothing, bedding, dressings etc)
that has been in contact with this
product burns more easily and is a
serious fire hazard. Washing
clothing and bedding ma

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oilatum Cream
Oilatum Junior Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0%
w/w
in a cream base.
Also contains cetostearyl alcohol and potassium sorbate.
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Cream.
A white to off-white cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oilatum Cream is indicated in the treatment of contact dermatitis,
atopic
eczema, senile pruritus, ichthyosis and related dry skin conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oilatum Cream may be used as often as required. Apply to the affected
area
and rub in well. It is especially effective after washing when the
sebum
content
of
the
stratum
corneum
may
be
depleted
resulting
in
excessive
moisture loss.
Oilatum Cream is suitable for adults, children and the elderly.
4.3
CONTRAINDICATIONS
Should not be used in patients with known hypersensitivity to any of
the
ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Oilatum Cream should be used with caution in patients with a known
sensitivity or allergy to white soft paraffin or light liquid paraffin
(WSP-LLP)
or to any of the excipients in the preparation.
Cetostearyl alcohol and potassium sorbate may cause local skin
reactions
(e.g. contact dermatitis).
Instruct patients not to smoke or go near naked flames – risk of
severe
burns. Fabric (clothing, bedding, dressings etc) that has been in
contact
with this product burns more easily and is a serious fire hazard.
Washing
clothing and bedding may reduce product build-up but not totally
remove
it.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None.
4.6
FERTILITY, PREGNANCY AND LACTATION
FERTILITY
There are no data on the use of topical Oilatum Cream on human
fertility
PREGNANCY
There are no data on the use of topical Oilatum Cream in pregnant
women. No
effects during pregnancy are anticipated, since systemic exposure to
WSP-
LLP i