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.

Active Ingredient

Ketoconazole 1%

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


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Ketoconazole 1%

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.

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


Advanced Ingredient Data


Raw Label Data

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