87255-008

87255-008
SPL v2
SPL
SPL Set ID 482c0243-1073-f578-e063-6294a90adf5c
Route
TOPICAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ketoconazole (1 mg)
Inactive Ingredients
Hydroxypropyl Methylcellulose Cocamide Mea Polyquaternium-7 Sodium Hydroxide Citric Acid Disperse Blue 1 Hydrochloric Acid Sodium Cocoyl Sarcosinate Tetrasodium Edta Water Sodium Benzoate Sodium Chloride Mentha Piperita (peppermint) Oil Glycol Distearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-12

Description

Ketoconazole 1%


Medication Information

Description

Ketoconazole 1%

Uses

controls flaking, scaling and itching associated with dandruff

Section 50565-1

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away.

Section 51945-4

Section 55105-1

Anti-Fungal shampoo

Section 55106-9

Ketoconazole 1%

Warnings

For external use only

Directions

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

- ask a doctor

Do Not Use

- on scalp that is broken or inflamed

- if you are allergic to ingredients in this product

Other Information

- store at 20℃ to 25℃(68°F-77°F)

- see top panel for lot number and expiration date

Inactive Ingredients

blue l, citric acid, cocamide MEA. mentha Piperita Oil.glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7.sodium benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide, tetrasodium EDTA, water

When Using This Product

- avoid contact with eyes

- if product gets into eyes,rinse thoroughly with water

Stop Use and Ask A Doctor If

- rash appears

- condition worsens or does not improve in 2-4 weeks


Structured Label Content

Uses

controls flaking, scaling and itching associated with dandruff

Section 50565-1 (50565-1)

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-Fungal shampoo

Section 55106-9 (55106-9)

Ketoconazole 1%

Warnings

For external use only

Directions

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

- ask a doctor

Do Not Use (Do not use)

- on scalp that is broken or inflamed

- if you are allergic to ingredients in this product

Other Information (Other information)

- store at 20℃ to 25℃(68°F-77°F)

- see top panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

blue l, citric acid, cocamide MEA. mentha Piperita Oil.glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7.sodium benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide, tetrasodium EDTA, water

When Using This Product (When using this product)

- avoid contact with eyes

- if product gets into eyes,rinse thoroughly with water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

- rash appears

- condition worsens or does not improve in 2-4 weeks


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)