83771-003

Manufacturer
Inner Mongolia Green source pharmaceutical Products Co., LTD
Effective date
2024-08-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:57:06

Label at a glance#

ProductRoyceDerm Coal Tar Scalp Relief Shampoo.
Active ingredientCOAL TAR
Label structure13 sections

Dosage and administration

Applyshampoo, massage into scalp, and leave onhair for 5 minutes to allow maximum absorptionThen rinse and repeat as needed, Use at leasttwice a week or as directed by a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Coal Tar 0.5%

Purpose

OTC - PURPOSE SECTION

Helps control symptoms of dandruff,psoriasis, and seborrheic dermatitis.

Use

INDICATIONS & USAGE SECTION

Helps control symptoms of dandruffpsoriasis, and seborrheic dermatitis

Warnings

WARNINGS SECTION

For external use only.*Awoid prolonged use without consulting a doctor*Consult a doctor before using this productwith other forms of psoriasis therapy suchas ultraviolet radiation or prescription drugsConsult a doctor before use if you have acondition that covers a large area of the bodyAvoid contact with eyes.lf contact occursrinse eyes thoroughly with water.. Discontinue use and consult a doctor if conditiorworsens or does not improve after regular use.Keep out of reach of children. lf swallowedget medical help or contact a Poison ControCenter.

Do not use

OTC - DO NOT USE SECTION

Not for pregnant women and infants

When Using

OTC - WHEN USING SECTION

Avoid contact with eyes.lf contact occursrinse eyes thoroughly with water.

Stop Use

OTC - STOP USE SECTION

Discontinue use and consult a doctor if conditiorworsens or does not improve after regular use

Ask Doctor

OTC - ASK DOCTOR SECTION

Awoid prolonged use without consulting a doctor*Consult a doctor before using this productwith other forms of psoriasis therapy suchas ultraviolet radiation or prescription drugs

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please keep this product out of the reach of children. If a child accidentally ingests it, please call the emergency center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Applyshampoo, massage into scalp, and leave onhair for 5 minutes to allow maximum absorptionThen rinse and repeat as needed, Use at leasttwice a week or as directed by a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua),Melaleuca Alternifolia Leaf Oil,Polygonum Multiflorum,Cnidium Monnieri,Kochia Scoparia,Gleditsia Sinensis,Smilax glabra,Cocamide MEA,Citric Acid,Guar Gum,Ethylene Glycol Stearate

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83771-00383771-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
33c172ec-c44e-65f6-e063-6394a90a3fe21f13a58c-5fe5-7217-e063-6294a90aa8692025-04-27WarningsExact identifier
spl set id: 1f13a58c-5fe5-7217-e063-6294a90aa869

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.