Not scheduled (OTC)

Topical

• Topical ointment: 5%, 10%

• Topical lotion: 1%, 5%

• Topical shampoo: 0.5%, 1%, 2%, 5%

• Soap bar: 1%, 1.5%

• Emulsion: 5%, 10%

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Chronic Plaque Psoriasis (Scalp and Body)

Adults:

Parameter Recommendation

Starting dose Apply thin layer of 5–10% ointment/lotion once daily to affected areas

Titration May increase to twice daily application if tolerated

Usual maintenance dose Once or twice daily application

Maximum dose No defined maximum; avoid extensive full-body application due to potential systemic absorption

Clinical notes:

• Best suited for thick, chronic plaques; avoid in acute or exudative lesions

• Often combined with topical corticosteroids or salicylic acid for enhanced efficacy

• Apply preferably at night due to staining, odour, and photosensitivity risk

• Leave ointment on skin for several hours or overnight before washing off

1. Seborrhoeic Dermatitis of the Scalp

Adults:

Parameter Recommendation

Starting dose Coal tar shampoo (0.5–2%); apply to wet scalp, massage, leave for 5–10 minutes, then rinse

Titration Not applicable

Usual maintenance dose 2–3 times per week initially; reduce to once weekly for maintenance

Maximum dose No defined maximum; avoid prolonged high-concentration use

Clinical notes:

• Effective as adjunct for scalp scaling control

• May alternate with ketoconazole or zinc pyrithione shampoos

• Response typically seen after 2–4 weeks of regular use

1. Lichen Simplex Chronicus

Adults:

Parameter Recommendation

Starting dose Apply 5–10% ointment once daily

Titration May increase to twice daily if tolerated

Usual maintenance dose Once to twice daily

Maximum dose No defined maximum for localised application

Clinical notes: Usually used short-term in conjunction with topical corticosteroids.

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence Basis

Atopic Dermatitis (chronic lichenified areas) Apply 5% ointment 1–2 times daily Short-term; avoid in acute flares OFF-LABEL; Specialist only Indian dermatological practice

Palmoplantar Keratoderma Apply 5–10% ointment once to twice daily Intermittent courses OFF-LABEL; Specialist only Specialist dermatologist practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Psoriasis in Children

Age ≥2 years:

2–12 years 1–5% lotion/ointment Apply lowest strength once daily Increase frequency to twice daily if tolerated Once to twice daily Use ≤5% concentration

12 years 5–10% ointment Apply once daily May increase to twice daily Once to twice daily Standard adult concentrations

Safety monitoring: Monitor for skin irritation, allergic reactions, and phototoxicity at each visit.

1. Paediatric Seborrhoeic Dermatitis

Age ≥2 years:

Parameter Recommendation

Starting dose Coal tar shampoo 0.5–1%; apply to scalp, leave for 5 minutes, rinse thoroughly

Titration Not applicable

Usual maintenance dose Twice weekly

Maximum dose No defined maximum

Clinical notes: Avoid eye contact. Consider alternation with mild antifungal shampoo.

Secondary Indications — Paediatrics (Off-label)

Not routinely recommended for acute eczema in children.

Age restriction: NOT RECOMMENDED in infants (<2 years) due to immature skin barrier and higher systemic absorption risk. Use below 2 years only under strict paediatric dermatologist supervision in exceptional circumstances.

No adjustment required. Minimal systemic absorption with appropriate topical use.

• Hypersensitivity to coal tar or formulation components

• Acute inflamed, broken, weeping, or infected skin

• Pustular psoriasis

• Photodermatitis or known photosensitivity disorders

• History of tar acne or folliculitis from prior coal tar use

• Application to acutely sunburned skin

• Application to face, genital area, or intertriginous zones — increased irritation risk

• Photosensitivity — advise sun avoidance for 24–72 hours after application

• Fair-skinned individuals — higher photosensitivity risk

• Patients undergoing phototherapy — timing coordination required

• May exacerbate folliculitis or acneiform eruptions

• Chronic extensive use — theoretical carcinogenic concerns (mainly occupational exposure data; no definitive risk at therapeutic doses)

• Staining of skin, hair, nails, and clothing — may limit adherence

Parameter Recommendation

Overall safety Not recommended routinely; avoid extensive or prolonged use

Preferred alternatives Emollients, mild topical corticosteroids, calcipotriol (under specialist supervision)

When it may be used Limited use for severe scalp psoriasis/seborrhoea — low-strength shampoo, short duration, minimal surface area

What to monitor Local irritation; systemic absorption low but avoid overuse

Parameter Recommendation

Compatibility Compatible with breastfeeding if not applied near breast or nipple area

Preferred alternatives Emollients, mild topical corticosteroids

Drug levels in milk Negligible with topical use

Infant monitoring Avoid direct skin contact between treated areas and infant; monitor for local irritation if contact occurs

• Starting dose: Use lower strength formulations (1–5%); apply once daily initially

• Titration: Increase frequency gradually based on tolerability

• Extra risks:

• Age-related skin thinning increases irritation susceptibility

• Increased dryness may exacerbate skin discomfort

• Cumulative systemic toxicity unlikely with topical application

Not applicable — no clinically significant major drug interactions with topical coal tar at therapeutic doses.

Drug/Therapy Interaction Recommendation

Topical salicylic acid May enhance coal tar penetration and increase irritation risk Apply sequentially (not simultaneously); allow time between applications

UVB phototherapy Coal tar enhances photosensitivity (Goeckerman regimen principle) Coordinate timing carefully; coal tar may be applied before UVB under specialist supervision; increased burn risk if timing inappropriate

Other topical keratolytics Additive irritation potential Use sequentially; monitor for excessive irritation

• Irritant contact dermatitis

• Folliculitis

• Skin discolouration (brownish staining)

• Photosensitivity reactions

• Unpleasant odour

• Staining of clothes, bedding, and hair

• Dryness of treated skin

• Allergic contact dermatitis — discontinue if suspected; patch testing may be required

• Severe phototoxic reactions — requires immediate discontinuation and sun protection

• Exacerbation of acute eczema or pustular psoriasis

• Tar acne (comedonal and pustular eruptions)

• Theoretical carcinogenicity risk — associated with chronic high-dose occupational exposure; not established at therapeutic topical doses

Phase Parameters

Baseline Clinical inspection of skin; exclude active infections, sunburn, or acute inflammation

After initiation Assess for irritation and photosensitivity reactions within 7–14 days

Long-term Clinical response assessment at 4 weeks; reassess need for continuation; no routine laboratory monitoring required for topical use

• Cetrilak® lotion

• Targel® shampoo

• Tarscalp® shampoo

• Trecivon® ointment

• Alphatar® ointment

• Ionax-T® shampoo

• Tarj-D® soap

Note: Strengths and combinations vary by brand; some contain additional ingredients such as salicylic acid or sulfur.

Note: Not included in NLEM; not under NPPA price control. MRP varies by brand and formulation.

• Coal tar remains a useful and cost-effective option for chronic stable plaque psoriasis, particularly scalp involvement

• Avoid use on acutely inflamed, exudative, or pustular lesions — may exacerbate inflammation

• Counsel patients regarding odour and staining — major factors affecting adherence; night-time application and use of old clothing/bedding recommended

• For scalp psoriasis, an alternating regimen with mild corticosteroid scalp lotion or ketoconazole shampoo often improves outcomes

• Avoid application immediately before phototherapy sessions without specialist coordination — enhanced phototoxicity risk

• Response to tar shampoo may take 2–4 weeks — advise patients to continue regular use before concluding inefficacy

coal tar; psoriasis; seborrhoeic dermatitis; scalp dermatitis; keratolytic; photosensitivity; topical therapy; dermatology; OTC; paediatric-safe

RxIndia v1.0 — 07 May 2025

• CDSCO product database

• Indian Pharmacopoeia

• National Formulary of India (NFI)

• AIIMS Dermatology formulary

• IADVL Standard Treatment Guidelines

• API Textbook of Medicine

• Indian tertiary care dermatology protocols