Initial Drug Listing - Scalp Treatment Shampoo

Initial Drug Listing - Scalp Treatment Shampoo
SPL v1
SPL
SPL Set ID 30b75584-3a1e-c125-e063-6294a90acaa7
Route
TOPICAL
Published
Effective Date 2025-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ketoconazole (10 mg)
Inactive Ingredients
Phellodendron Amurense Bark Stemona Sessilifolia Root Gleditsia Sinensis Thorn Cnidium Monnieri Fruit Murraya Paniculata Root Bark Dictamnus Dasycarpus Root Bark Stellera Chamaejasme Whole Melaleuca Alternifolia (tea Tree) Leaf Oil Citric Acid Smilax Glabra Tuber Water Sophora Flavescens Root Mentha Canadensis Top Oil Euphorbia Hirta Mosla Cavaleriei Whole Viola Yezoensis Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-31
Description

ketoconazole 1%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Targets Stubborn Dandruff, Seborrheic Dermatitis, and itching
  • ​Prevention, Treatment, and control of fungus that can cause dandruff
Dosage and Administration

adults and children

12 years and over

• wet hair thoroughly

• apply shampoo, generously lather, rinse thoroughly. Repeat

• use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff

Children under 12 years old • Ask a doctor

Description

ketoconazole 1%

Section 50565-1

If swallowed, get medical help or contact a Posion Control Center immediately

Section 50566-9

If the rash appears or the condition worsens does not improve in 2-4 weeks.

Section 50567-7

do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Section 50570-1

on the scalp that is broken or inflamed if you are allergic to ingredients in this product

Section 51727-6

Citric Acid, Herba Violae, Euphorbia Hirta, Murraya Paniculata ,Mentha Canadensis, Sophora Flavescens, Dittany Bark, Glabrous Greenbrier Rhizome, Mosla Cavaleriei Levl ,Stellera Chamaejasme, Huang Bai, Sessile Stemona Root, Gleditsia Sinensis, Common Cnidium Fruit, Fructus Kochiae, Tea Tree Oil, Water

Section 51945-4

Section 53413-1

[email protected]

Section 53414-9

ask a doctor before use

Section 55105-1

Anti Dandruff

Section 55106-9

ketoconazole 1%

Section 60561-8

• store at 20°C to 25°C (68°F-77°F)

• see top panel for lot number and expiration date

Structured Label Content

Indications and Usage (34067-9)
  • Targets Stubborn Dandruff, Seborrheic Dermatitis, and itching
  • ​Prevention, Treatment, and control of fungus that can cause dandruff
Dosage and Administration (34068-7)

adults and children

12 years and over

• wet hair thoroughly

• apply shampoo, generously lather, rinse thoroughly. Repeat

• use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff

Children under 12 years old • Ask a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Posion Control Center immediately

Section 50566-9 (50566-9)

If the rash appears or the condition worsens does not improve in 2-4 weeks.

Section 50567-7 (50567-7)

do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Section 50570-1 (50570-1)

on the scalp that is broken or inflamed if you are allergic to ingredients in this product

Section 51727-6 (51727-6)

Citric Acid, Herba Violae, Euphorbia Hirta, Murraya Paniculata ,Mentha Canadensis, Sophora Flavescens, Dittany Bark, Glabrous Greenbrier Rhizome, Mosla Cavaleriei Levl ,Stellera Chamaejasme, Huang Bai, Sessile Stemona Root, Gleditsia Sinensis, Common Cnidium Fruit, Fructus Kochiae, Tea Tree Oil, Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

[email protected]

Section 53414-9 (53414-9)

ask a doctor before use

Section 55105-1 (55105-1)

Anti Dandruff

Section 55106-9 (55106-9)

ketoconazole 1%

Section 60561-8 (60561-8)

• store at 20°C to 25°C (68°F-77°F)

• see top panel for lot number and expiration date

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:48.448343 · Updated: 2026-03-14T23:08:08.103878