Oilatum Emollient

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Liquid paraffin light

Available from:

Thornton & Ross Ltd

INN (International Name):

Liquid paraffin light

Dosage:

634mg/1ml

Pharmaceutical form:

Bath additive

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13020101; GTIN: 5011091101557 5011091101571 5011091107528

Patient Information leaflet

DIRECTIONS
ACTIVE INGREDIENTS
WARNINGS
light liquid paraffin BP 63.4% w/w
OTHER INGREDIENTS: Acetylated Lanolin Alcohols, Isopropyl
Palmitate, Macrogol 400 Dilaurate, Macrogol Ester, Fragrance
(containing geraniol, linalool, coumarin, limonene, citronellol,
eugenol, hydroxycitronellal and hexyl cinnamaldehyde)
PL 00240/0463.
Date of information: September 2020
OILATUM EMOLLIENT should always be used with water.
ADULTS, INCLUDING THE ELDERLY: Add 1-3 capfuls to an
8 inch bath of water. Bathe for 10-20 minutes. Pat dry with
a towel. Alternatively, rub a small amount onto wet skin,
rinse off and pat dry.
INFANTS AND CHILDREN: As above, or add ½ to 2 capfuls to
a small bath of water. Apply gently over the entire body with
a sponge. Pat
dry with a towel.
SKIN CLEANSING: Rub a small amount
into wet skin, rinse off
and pat dry.
FIRE HAZARD. DO NOT SMOKE OR GO NEAR NAKED
FLAMES; CLOTHING & BEDDING WITH THIS PRODUCT
DRIED ON THEM CAN CATCH FIRE EASILY.
Take care against slipping in the bath. Avoid contact with
eyes. 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 may reduce product
build-up but not totally remove it. This medicine contains lanolin
which may cause local skin reactions (e.g. contact dermatitis).
This medicine contains fragrance with geraniol, linalool,
coumarin, limonene, citronellol, eugenol, hydroxycitronellal
and hexyl cinnamaldehyde which may cause allergic
reactions. Reporting of side effects: If you get any side effects
e.g. rash, skin irritation, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed on this label.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine. USE THIS MEDICINE ONLY ON YOUR SKIN.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Summary of Product characteristics

OBJECT 1
OILATUM EMOLLIENT
Summary of Product Characteristics Updated 20-Jun-2022 | Thornton &
Ross Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Oilatum Emollient
Oilatum Soothing Bath Emollient
2. Qualitative and quantitative composition
Light Liquid Paraffin 63.4% w/w
Excipient(s) with known effect
Acetylated Lanolin Alcohol
Fragrance (Contains: geraniol, linalool, coumarin, limonene,
citronellol, eugenol, hydroxycitronellal and
hexyl cinnamaldehyde)
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Liquid Bath Additive
4. Clinical particulars
4.1 Therapeutic indications
Oilatum Emollient is indicated in the treatment of contact dermatitis,
atopic dermatitis, senile pruritus,
ichthyosis and related dry skin conditions. Oilatum Emollient replaces
oil and water and hydrates the keratin.
Oilatum Emollient is particularly suitable for infant bathing. The
preparation also overcomes the problem of
cleansing the skin in conditions where the use of