initial drug listing - roycederm seborrheic dermatitis & dandruff medicated cleansing bar

initial drug listing - roycederm seborrheic dermatitis & dandruff medicated cleansing bar
SPL v1
SPL
SPL Set ID 3b98a83d-9c3b-9522-e063-6294a90a7033
Route
topical
Published
Effective Date 2025-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pyrithione zinc (4.52 g)
Inactive Ingredients
butyrospermum parkii (shea) butter glycerin sodium cocoyl isethionate polyquaternium-7 menthol tetrasodium edta adeps bovis olea europaea (olive) fruit oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-31
Description

Pyrithione Zinc 2%

Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Pyrithione Zinc 2%

Indications and Usage
  • Cleanse and dry skin.
  • Apply a thin layer to affected areas.
  • Use thricedaily or as directed by a doctor.
Dosage and Administration

Controls and reduces the symptoms of dandruff and seborrheic dermatitis

Description

Pyrithione Zinc 2%

Section 50565-1

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

Section 50566-9

if condition worsensor does not improve.

Section 50567-7

avoid contact with eyesIf contact occurs, rinse thoroughly with water.

Section 50569-3

you have a conditionthat covers a large area of the body.

Section 51727-6

Tetrasodium EDTA, Sodium Cocoyl Isethionate, Glycerin, Polyquaternium-7, Menthol, Adep Bovis, Olea Europaea(Olive) fruit Oil, Butyrospermum Parkii (Shea Butter)

Section 51945-4

Section 53413-1

Email [email protected]

Section 53414-9

ask a healthprofessional before use.

Section 55105-1
  • Anti-dandruff
  • Anti-seborrheic dermatitis
Section 60561-8

store at room temperature.

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Pyrithione Zinc 2%

Indications and Usage (34067-9)
  • Cleanse and dry skin.
  • Apply a thin layer to affected areas.
  • Use thricedaily or as directed by a doctor.
Dosage and Administration (34068-7)

Controls and reduces the symptoms of dandruff and seborrheic dermatitis

Section 50565-1 (50565-1)

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

Section 50566-9 (50566-9)

if condition worsensor does not improve.

Section 50567-7 (50567-7)

avoid contact with eyesIf contact occurs, rinse thoroughly with water.

Section 50569-3 (50569-3)

you have a conditionthat covers a large area of the body.

Section 51727-6 (51727-6)

Tetrasodium EDTA, Sodium Cocoyl Isethionate, Glycerin, Polyquaternium-7, Menthol, Adep Bovis, Olea Europaea(Olive) fruit Oil, Butyrospermum Parkii (Shea Butter)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email [email protected]

Section 53414-9 (53414-9)

ask a healthprofessional before use.

Section 55105-1 (55105-1)
  • Anti-dandruff
  • Anti-seborrheic dermatitis
Section 60561-8 (60561-8)

store at room temperature.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:53.065254 · Updated: 2026-03-14T23:09:55.704959