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    Dermocalm Lotion

    Uploaded by

    Sai Krishna
    This document provides information on Dermocalm Lotion, which contains calamine (zinc oxide) and light liquid paraffin. It is indicated for reducing itching and smoothing the skin. The lotion contains calamine at 8% and light liquid paraffin at 10% in a base. It is for topical use on affected areas as needed by adults. No dosage information is provided for children or those with renal or hepatic impairment. It should not be used by those with an allergy to ingredients or before x-rays. Minimal systemic absorption is expected.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Dermocalm Lotion

    Uploaded by

    Sai Krishna
    125 views5 pages
    This document provides information on Dermocalm Lotion, which contains calamine (zinc oxide) and light liquid paraffin. It is indicated for reducing itching and smoothing the skin. The lotion contains calamine at 8% and light liquid paraffin at 10% in a base. It is for topical use on affected areas as needed by adults. No dosage information is provided for children or those with renal or hepatic impairment. It should not be used by those with an allergy to ingredients or before x-rays. Minimal systemic absorption is expected.

    Original Description:

    Itching lotion for all skin

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    © © All Rights Reserved

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    This document provides information on Dermocalm Lotion, which contains calamine (zinc oxide) and light liquid paraffin. It is indicated for reducing itching and smoothing the skin. The lotion contains calamine at 8% and light liquid paraffin at 10% in a base. It is for topical use on affected areas as needed by adults. No dosage information is provided for children or those with renal or hepatic impairment. It should not be used by those with an allergy to ingredients or before x-rays. Minimal systemic absorption is expected.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    125 views5 pages

    Dermocalm Lotion

    Uploaded by

    Sai Krishna
    This document provides information on Dermocalm Lotion, which contains calamine (zinc oxide) and light liquid paraffin. It is indicated for reducing itching and smoothing the skin. The lotion contains calamine at 8% and light liquid paraffin at 10% in a base. It is for topical use on affected areas as needed by adults. No dosage information is provided for children or those with renal or hepatic impairment. It should not be used by those with an allergy to ingredients or before x-rays. Minimal systemic absorption is expected.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    For the use only of Registered Medical Practitioners or a Hospital or a Laboratory

    DERMOCALM LOTION

    Calamine and Light Liquid Paraffin Lotion

    QUALITATIVE AND QUANTITATIVE COMPOSITION

    Calamine* IP 8 .0 % w/w
    Light Liquid Paraffin IP 10.0 % w/w
    in a lotion base

    *Calamine is Zinc Oxide with a small proportion of ferric oxide.

    PHARMACEUTICAL FORM

    Lotion.

    CLINICAL PARTICULARS

    Therapeutic Indications

    DERMOCALM LOTION is indicated for use as an anti-pruritic and smoothening agent.

    Posology and Method of Administration

    Adults

    For Topical/cutaneous use.

    Dermocalm lotion to be applied gently on the affected area of the skin.

    Apply on the affected zone as many times as required.

    Children

    There are no relevant data available.

    Elderly

    There are no relevant data available.

    Renal impairment

    There are no relevant data available.

    Hepatic impairment

    There are no relevant data available.

    1
    Contraindications

    DERMOCALM LOTION is contraindicated in hypersensitivity to any of the ingredients of this


    product.

    Special warnings and Special Precautions for Use

    X-ray examination: Calamine should not be applied onto the skin before an X-ray examination
    because it may affect the outcome of the radiograph.

    Light liquid paraffin should be used with caution in patients with a known hypersensitivity or
    allergy to light liquid paraffin or to any of the excipients in the preparation.

    Discontinue use, if skin irritation occurs.

    Avoid entry of Dermocalm lotion in the eyes or mouth.

    Interaction with Other Medicaments and Other Forms of Interaction

    Benzyl penicillin

    Zinc oxide is incompatible with benzyl penicillin.

    Fatty acids

    Zinc oxide reacts slowly with fatty acid in oils and fats to produce the corresponding fatty acid
    esters.

    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 relevant data available.

    Pregnancy and Lactation

    The safety of DERMOCALM LOTION during pregnancy and lactation has not been established.

    No adverse effects have been reported with calamine.

    No effects of light liquid paraffin during pregnancy are anticipated, since systemic exposure to
    light liquid paraffin is expected to be low.

    It is not known if light liquid paraffin is excreted in human milk. Risk to the infant is likely to
    be low since systemic exposure is low.

    2
    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 are no relevant data available.

    Undesirable effects

    Calamine

    There are no relevant data available.

    Light liquid paraffin

    Adverse drug reactions (ADR) are listed below by MedDRA system organ class and by
    frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10),
    uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000),
    including isolated reports.

    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

    There are no relevant data available for calamine.

    The product is intended for cutaneous use only Accidental ingestion of light liquid paraffin
    may cause gastrointestinal irritation with nausea, vomiting and diarrhea.

    Treatment

    No special procedures or anti-dote is likely to be necessary. In case of overuse wash off with
    soap and hot water. 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

    Pharmacotherapeutic Group

    3
    Calamine : Emollients and protectives; ATC Code: D02AB.

    Light Liquid Paraffin: Dermatologicals, other emollients and protectives; ATC code: D02AX.

    Mechanism of Action/ Pharmacodynamic effects

    Calamine

    Calamine has a mild astringent antipruritic and soothing action on the skin. Calamine has
    astringent effects in the skin or mucous membranes by coagulating protein. The protein
    precipitates which forms a protective coat, allowing new tissue to regenerate underneath. It is
    commonly used to reduce the extent of weeping in dermatitis and to check oozing and discharge
    in other mild disorders.

    Light Liquid Paraffin

    Light liquid paraffin exerts an emollient effect by forming an occlusive film on the stratum
    corneum.

    Pharmacokinetic Properties

    Calamine

    Calamine is unlikely to be absorbed through the skin.

    Light Liquid Paraffin

    There have been no studies to investigate the pharmacokinetics of cutaneously applied light
    liquid paraffin. It is chemically and biologically inert; systemic uptake is considered to be
    minimal (<1%).

    Preclinical safety data

    There are no relevant data available.

    PHARMACEUTICAL PARTICULARS

    List of excipients

    Aloe Vera gel, Glycerin, Bentonite, Brij S2-SO-(TH), Brij-S21-FL-(TH), Silicone Oil 350 cs,
    Dow corning 1403 fluid, Magnesium Aluminium Silicate, Perfume composition 12447, Citric
    Acid Monohydrate, Methylparaben, Propylparaben.

    Incompatibilities

    There are no relevant data available.

    Shelf life

    4
    The expiry date is indicated on the label and packaging.

    Special Precautions for Storage

    Store at a temperature not exceeding 30°C.


    Do not freeze

    Keep out of reach of children.

    Nature and Specifications of Container

    Bottle in a carton.

    All pack presentations may not be marketed in the country.

    Instruction for Use/Handling:

    For external use only.

    Shake the bottle before use.

    There are no other special requirements for use or handling of this product.

    For further information please contact:


    GlaxoSmithKline Pharmaceuticals Limited
    Registered Office
    Dr Annie Besant Road, Worli,
    Mumbai 400030. India.

    Trade marks are owned by or licensed to the GSK group of companies

    Version: DER/PI/IN/2018/03 dated 21 November 2018

    Adapted from Calamine NCDS v 02 dated 08-June-2012 and Light Liquid Paraffin Cx GDS
    01 dated 24-September-2012.

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