Doublebase Emollient Bath Additive
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doublebase Emollient Bath Additive.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid Paraffin 65.0% w/w
For excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Bath additive. Dye- and fragrance-free white to off white mobile liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin disorders.
4.2 Posology and method of administration
Adults, including the elderly:
Shake the bottle to mix contents and add 15 to 20 ml (l'A to 2 inner capfuls) to a standard bath of water (20 cm depth). Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Pat dry with a towel.
Infants and children:
Shake the bottle to mix contents and add 5 to 10 ml (A to 1 inner capful) to a small bath or wash basin of water. Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Alternatively, repeatedly gently sponge over the affected areas. Pat dry with a towel.
There is no differentiation between the dosage quantities for the symptomatic relief of the conditions listed.
4.3 Contraindications
Sensitivity to any of the ingredients
4.4 Special warnings and precautions for use
Take care not to slip in the bath. Surfaces that have been in contact with the product should be cleaned with a proprietary detergent. Keep out of the reach of children. For external use only.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
The constituents are not percutaneously absorbed or toxic if ingested. There is no evidence of safety of the drug used in pregnancy or lactation, but the active constituent has been in widespread use and in similar preparations for many years without apparent ill consequence.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Contact sensitivity reactions or mild irritant reactions may occur occasionally. In either case, treatment should be discontinued.
4.9 Overdose
Accidental ingestion may result in a purgative action due to the liquid paraffin and the oily nature of the product. Treat symptomatically. Fluid and electrolyte replacement may be necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: D02AX - Other emollients
For dry skin conditions it is important to use an emollient while bathing. Doublebase Emollient Bath Additive contains 65% Liquid Paraffin for its moisturising and skin softening properties, and is specially formulated to disperse in bath water.
5.2 Pharmacokinetic properties
The active constituent is not absorbed percutaneously. Pharmacokinetic particulars are thus not relevant.
5.3 Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Isopropyl myristate Glycerol
Macrogol cetostearyl ether (cetomacrogol)
Cetostearyl alcohol Phenoxyethanol Purified Water
6.2 Incompatibilities
None known
6.3 Shelf life
50ml, 200ml, 500ml: 30 months
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
50, 200, 500, or 1000ml white high density polyethylene bottle fitted with a polypropylene screw cap.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Diomed Developments Limited T/A Dermal Laboratories Tatmore Place Gosmore
Hitchin
Hertfordshire SG4 7QR United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00173/0200
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/03/2006 / 05/11/2010
10 DATE OF REVISION OF THE TEXT
31/07/2013