GEMBOOXT KETOCONAZOLE 1% MEDICATED SHAMPOOS- ketoconazole liquid

Gembooxt Ketoconazole 1% Medicated Shampoos by

Drug Labeling and Warnings

Gembooxt Ketoconazole 1% Medicated Shampoos by is a Otc medication manufactured, distributed, or labeled by Guangdong Quadrant Ecological Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ketoconazole 1%

PURPOSE

Anti-dandruff shampoo

INDICATIONS & USAGE

Controls flaking, scaling and itching associated with dandruff

WARNINGS

For external use only.

DO NOT USE

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

WHEN USING

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.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GEMBOOXT KETOCONAZOLE 1% MEDICATED SHAMPOOS 
ketoconazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76986-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAURYL LACTATE (UNII: G5SU0BFK7O)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BIOTIN (UNII: 6SO6U10H04)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPANEDIOL (UNII: 5965N8W85T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
GLYCERYL LAURATE (UNII: Y98611C087)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID (UNII: 2968PHW8QP)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76986-025-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2026
2	NDC: 76986-025-02	450 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2026
3	NDC: 76986-025-03	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/30/2026

Labeler - Guangdong Quadrant Ecological Technology Co., Ltd. (554532634)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Quadrant Ecological Technology Co., Ltd.		554532634	manufacture(76986-025)