76986-025 Gembooxt Ketoconazole 1% Medicated Shampoos

76986-025 Gembooxt Ketoconazole 1% Medicated Shampoos
SPL v1
SPL
SPL Set ID 49965e91-43c3-65d7-e063-6294a90abaec
Route
TOPICAL
Published
Effective Date 2026-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ketoconazole (0.01 g)
Inactive Ingredients
Lauryl Lactate Cocamidopropyl Betaine Glyceryl Caprylate Water Pentylene Glycol Biotin 1,2-hexanediol Ethylhexylglycerin Propanediol Potassium Hydroxide Glyceryl Laurate Caprylhydroxamic Acid Sodium Lauroyl Sarcosinate Phenoxyethanol Citric Acid Polyquaternium-10 (1000 Mpa.s At 2%) Edetate Disodium Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-30

Description

Ketoconazole 1%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Controls flaking, scaling and itching associated with dandruff

Dosage and Administration



For adults and children 12 years and older:

1. Wet hair thoroughly.

2. Apply shampoo, generously lather, rinse thoroughly. Repeat.

3. 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.

Description

Ketoconazole 1%

Section 50565-1

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

Section 50566-9

rash appears.

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

Section 50567-7

When using this products. Avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

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

Section 50570-1



on scalp that is broken or inflamed.

if you are allergic to ingredients in this product.

Section 51727-6

WATER

SODIUM LAUROYL SARCOSINATE

COCAMIDOPROPYL BETAINE

WATER

PARFUM

GLYCERYL CAPRYLATE

GLYCERYL LAURATE

PHENOXYETHANOL

WATER

LAURYL LACTATE

CITRIC ACID

POLYQUATERNIUM-10

DISODIUM EDTA

HYDROLYZED RHODOPHYCEAE EXTRACT

BUTYLENE GLYCOL

1,2-HEXANEDIOL

PENTYLENE GLYCOL

PROPANEDIOL

CAPRYLHYDROXAMIC ACID

ETHYLHEXYLGLYCERIN

BIOTIN

POTASSIUM HYDROXIDE

Section 51945-4

Section 55105-1

Anti-dandruff shampoo

Section 55106-9

Ketoconazole 1%


Structured Label Content

Indications and Usage (34067-9)

Controls flaking, scaling and itching associated with dandruff

Dosage and Administration (34068-7)



For adults and children 12 years and older:

1. Wet hair thoroughly.

2. Apply shampoo, generously lather, rinse thoroughly. Repeat.

3. 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.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

rash appears.

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

Section 50567-7 (50567-7)

When using this products. Avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

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

Section 50570-1 (50570-1)



on scalp that is broken or inflamed.

if you are allergic to ingredients in this product.

Section 51727-6 (51727-6)

WATER

SODIUM LAUROYL SARCOSINATE

COCAMIDOPROPYL BETAINE

WATER

PARFUM

GLYCERYL CAPRYLATE

GLYCERYL LAURATE

PHENOXYETHANOL

WATER

LAURYL LACTATE

CITRIC ACID

POLYQUATERNIUM-10

DISODIUM EDTA

HYDROLYZED RHODOPHYCEAE EXTRACT

BUTYLENE GLYCOL

1,2-HEXANEDIOL

PENTYLENE GLYCOL

PROPANEDIOL

CAPRYLHYDROXAMIC ACID

ETHYLHEXYLGLYCERIN

BIOTIN

POTASSIUM HYDROXIDE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-dandruff shampoo

Section 55106-9 (55106-9)

Ketoconazole 1%


Advanced Ingredient Data


Raw Label Data

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