For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory OILATUM EMOLLIENT. Light Liquid Paraffin Emollient

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1 For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory OILATUM EMOLLIENT Light Liquid Paraffin Emollient QUALITATIVE AND QUANTITATIVE COMPOSITION Light Liquid Paraffin IP Base q.s. 63.4% w/w PHARMACEUTICAL FORM Bath additive (liquid) CLINICAL PARTICULARS Therapeutic Indications OILATUM EMOLLIENT is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions Posology and Method of Administration For cutaneous use only. OILATUM EMOLLIENT should always be used with water, either added to bath water, applied to wet skin or used as a shower gel. OILATUM EMOLLIENT is an effective cleanser and should be used instead of soap to cleanse the skin. OILATUM EMOLLIENT may be used as frequently as necessary. Adults, adolescents and children In an eight inch (20 cm) bath of water add 1 3 capfuls (10 30 ml) (1 capful is 10 ml). Mix well. Soak for minutes. Gently pat the skin dry with a clean towel. In cases of extensive areas of dry skin ensure complete coverage by immersion. For skin cleansing, apply a small amount of OILATUM EMOLLIENT onto wet skin. Rinse and gently pat the skin dry with a clean towel.

2 Infants Add ½ - 2 capfuls (5 20 ml) to a basin of water (approximately 15 litres). Apply over entire body with a sponge. Gently pat the skin dry with a clean towel. Elderly No dosage adjustment is required in the elderly. Renal impairment No dosage adjustment is necessary. Systemic exposure to OILATUM EMOLLIENT is expected to be low following cutaneous administration because percutaneous absorption of OILATUM EMOLLIENT is very low (see Pharmacokinetics Properties). Hepatic impairment No dosage adjustment is necessary. Systemic exposure to OILATUM EMOLLIENT is expected to be low following cutaneous administration because percutaneous absorption of OILATUM EMOLLIENT is very low (see Pharmacokinetics Properties). Contraindications No contraindications identified. Special Warnings and Special Precautions for Use OILATUM EMOLLIENT should be used with caution in patients with a known sensitivity or allergy to OILATUM EMOLLIENT or to any of the excipients in the preparation. Interaction with Other Medicaments and Other Forms of Interaction No drug interaction studies have been conducted with cutaneous Light Liquid Paraffin. Considering the low level of systemic absorption, drug interactions are unlikely to occur. Pregnancy and Lactation Fertility There are no data on the use of cutaneous Light Liquid Paraffin on human fertility. Pregnancy No effects during pregnancy are anticipated, since systemic exposure to OILATUM EMOLLIENT is expected to be low.

3 Lactation It is not known if OILATUM EMOLLIENT is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low. Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding. Effects on Ability to Drive and Use Machines There have been no studies to investigate the effect of OILATUM EMOLLIENT on driving performance or the ability to operate machinery. No effects are anticipated based on the adverse reaction profile. Undesirable Effects Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common ( 1/10), common ( 1/100 and <1/10), uncommon ( 1/1,000 and <1/100), rare ( 1/10,000 and <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data). Post-marketing data Skin and Subcutaneous Tissue Disorders Rare: Application site reactions including application site irritation, rash, erythema, pruritus Immune System Disorders Rare: Application site hypersensitivity reactions including application site dermatitis Overdose Symptoms and signs The product is intended for cutaneous use only. Accidental ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea. Treatment In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available. PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties

4 Pharmacotherapeutic Group Dermatologicals, other emollients and protectives (ATC code : D02AX ) Mechanism of action Light liquid paraffin is an emollient widely used in the treatment of eczema and related dry skin conditions. Pharmacodynamic effects Light liquid paraffin exerts an emollient effect by forming an occlusive film on the stratum corneum. Pharmacokinetic Properties There have been no studies to investigate the pharmacokinetics of cutaneously applied OILATUM EMOLLIENT. It is chemically and biologically inert; systemic uptake is considered to be minimal (<1%). Preclinical Safety Data Non-clinical studies have not been conducted with OILATUM EMOLLIENT. PHARMACEUTICAL PARTICULARS List of Excipients Acetylated Lanolin Alcohol, Isopropyl Palmitate, Polyethylene Glycol 400 dilaurate, Polyoxyethylene 40 sorbital septaoleate (Arlatone T), Floral Spice Incompatibilities No incompatibilities have been identified. Shelf Life 36 months. The expiry date is indicated on the label and packaging. Special Precautions for Storage Store in a cool place. Keep out of reach of children.

5 Nature and Specification of Container 100 ml HDPE bottle Instructions for Use / Handling For external use only. Refer section Posology and Method of Administration for information. No other special requirements. For further information please contact: Stiefel India Private Limited, Registered office : 401 & 402, A Wing, 4th Floor, Floral Deck Plaza, Opp. Rolta Bhavan, Central MIDC Road, Andheri ( E ), Mumbai OILATUM is a trademark of the GlaxoSmithKline group of companies Version OLE/PI/IN/2013/01 dated 02 September 2013 Adapted from GDS Version 01 dated 24 September 2012