FDA.reportPublic FDA data

76986-025 Gembooxt Ketoconazole 1% Medicated Shampoos

Manufacturer
Guangdong Quadrant Ecological Technology Co., Ltd.
Effective date
2026-08-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-01 13:02:28

Label at a glance#

ProductGembooxt Ketoconazole 1% Medicated Shampoos
Active ingredientKETOCONAZOLE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole 1%

OTC - PURPOSE SECTION

Anti-dandruff shampoo

INDICATIONS & USAGE SECTION

Controls flaking, scaling and itching associated with dandruff

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION


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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION


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.

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2

label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136977863764681GTIN-13: 6977863764681
EAN-13: 6977863764681
GTIN storage (14 digits): 06977863764681		label2.jpg
BarcodeEAN-136977863764698GTIN-13: 6977863764698
EAN-13: 6977863764698
GTIN storage (14 digits): 06977863764698		label2.jpg
BarcodeEAN-136977863764704GTIN-13: 6977863764704
EAN-13: 6977863764704
GTIN storage (14 digits): 06977863764704		label2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76986-02576986-025-01, 76986-025-02, 76986-025-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
KETOCONAZOLER9400W927IACTIB
LAURYL LACTATEG5SU0BFK7OIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
WATER059QF0KO0RIACT
PENTYLENE GLYCOL50C1307PZGIACT
BIOTIN6SO6U10H04IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPANEDIOL5965N8W85TIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
GLYCERYL LAURATEY98611C087IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CITRIC ACID2968PHW8QPIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
EDETATE DISODIUM7FLD91C86KIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-30full-release2026-06-01 01:35:52

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gembooxt Ketoconazole 1% Medicated ShampoosKETOCONAZOLEGuangdong Quadrant Ecological Technology Co., Ltd.49965e91-43c3-65d7-e063-6294a90abaec2026-08-27WarningsExact identifier
ndc (package): 76986-025-01
ndc (package): 76986-025-03
ndc (package): 76986-025-02
ndc (product): 76986-025
ndc11 (package): 76986002501
ndc11 (package): 76986002502
ndc11 (package): 76986002503
spl id: 5a12f0c5-a8de-b428-e063-6294a90a6d75
spl set id: 49965e91-43c3-65d7-e063-6294a90abaec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.