RoyceDerm Coal Tar Scalp Relief Shampoo. by Inner Mongolia Green source pharmaceutical Products Co., LTD 83771-003 Complete

RoyceDerm Coal Tar Scalp Relief Shampoo. by

Drug Labeling and Warnings

RoyceDerm Coal Tar Scalp Relief Shampoo. by is a Otc medication manufactured, distributed, or labeled by Inner Mongolia Green source pharmaceutical Products Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROYCEDERM COAL TAR SCALP RELIEF SHAMPOO.- roycederm coal tar scalp relief shampoo shampoo 
Inner Mongolia Green source pharmaceutical Products Co., LTD

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83771-003 Complete

Active Ingredient

Coal Tar 0.5%

Purpose

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

Use

Helps control symptoms of dandruffpsoriasis, and seborrheic dermatitis

Warnings

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

Not for pregnant women and infants

When Using

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

Stop Use

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

Ask Doctor

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

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

Directions

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

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

Questions

Visit www.roycederm.com

PRINCIPAL DISPLAY PANEL

ROYCEDERM COAL TAR SCALP RELIEF SHAMPOO. 
roycederm coal tar scalp relief shampoo shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83771-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLEDITSIA SINENSIS WHOLE (UNII: FS3UB95UTG)
SMILAX GLABRA WHOLE (UNII: H51N91QNEB)
BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)
CNIDIUM MONNIERI WHOLE (UNII: GYR30735RE)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCOL CETEARATE (UNII: YHX98F77PB)
WATER (UNII: 059QF0KO0R)
REYNOUTRIA MULTIFLORA ROOT OIL (UNII: 1HIE915O2J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GUAR GUM (UNII: E89I1637KE)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83771-003-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	08/07/2024	04/27/2025

Labeler - Inner Mongolia Green source pharmaceutical Products Co., LTD (699508923)

Establishment
Name	Address	ID/FEI	Business Operations
Inner Mongolia Green source pharmaceutical Products Co., LTD		699508923	manufacture(83771-003) , label(83771-003)

Revised: 4/2025

Document Id: 33c172ec-c44e-65f6-e063-6394a90a3fe2

34390-5

Set id: 1f13a58c-5fe5-7217-e063-6294a90aa869

Version: 2

Effective Time: 20250427

 

Inner Mongolia Green