Oilatum Junior bath additive

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: 5011091102349 5011091105159 5011091102042 5011091102103 5011091107429

Patient Information leaflet

SOOTHING BATH TREATMENT FOR
ECZEMA AND DRY SKIN CONDITIONS
Fragrance free
REHYDRATES AND PROTECTS
SUITABLE FOR BABIES AND CHILDREN
light liquid paraffin
BATH ADDITIVE
JUNIOR
MARKETING
AUTHORISATION HOLDER:
Thornton & Ross Ltd.,
Linthwaite,
Huddersfield,
HD7 5QH, UK.
MANUFACTURER:
Delpharm Bladel
B.V., Industrieweg 1,
5331 AD Bladel,
The Netherlands.
PL 00240/0464
Date of information:
June 2020.
150 ML
DIRECTIONS
ALWAYS USE WITH WATER.
BATH: Add 1-3 capfuls to an 8 inch bath
of water. Soak for 10-20 minutes, pat dry.
INFANT BATH: Add ½ to 2 capfuls to a small
bath of water. Apply gently over the
entire body with a sponge. Pat dry.
SKIN CLEANSING: Rub a small
amount
into wet skin, rinse off and pat dry.
WARNINGS
Take care against slipping in the bath.
Avoid contact with eyes. Do not use if
allergic to any of the ingredients listed.
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.
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 carton. 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.
ACTIVE INGREDIENTS
light liquid
paraffin
63.4% w/w
OTHER
INGREDIENTS:
Acetylated
Lanolin Alcohols,
Isopropyl
Palmitate,
Polyethylene
Glycol
400
Dilaurate,
Macrogol Ester.
JUNIOR
JUNIOR
NEW SAFETY INFORMATION – SEE LABEL
92909772006
31035569.03
OILATUM JUNIOR
contains light liquid paraffin and has
been specially developed to produce
a soothing milky bath to treat eczema
and dry skin in children and babies.
OILATUM JUNIOR forms an emollient film
on the

Summary of Product characteristics

OBJECT 1
OILATUM JUNIOR BATH ADDITIVE
Summary of Product Characteristics Updated 19-Mar-2020 | 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 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 Junior
Oilatum Emollient Fragrance Free
2. Qualitative and quantitative composition
Light Liquid paraffin BP 63.4% w/w.
3. Pharmaceutical form
Liquid bath additive.
4. Clinical particulars
4.1 Therapeutic indications
Oilatum Junior is indicated in the treatment of contact dermatitis,
atopic dermatitis, senile pruritus,
ichthyosis and related dry skin conditions.
Route of administration: Topical
4.2 Posology and method of administration
Oilatum Junior may be used as frequently as necessary. Oilatum Junior
should always be used with water,
either added to the water or applied to wet skin.
For adults add 1-3 capfuls to an 8 inch bath of water. Soak for 10-20
minutes. Pat dry.
For infants, add ½-2 capfuls to a basin of water. Apply gently over
entire body with a sponge. Pat dry.
4.3 Contraindications
None.
4.4 Specia