1% KETOCONAZOLE- ketoconazole shampoo

1% ketoconazole by

Drug Labeling and Warnings

1% ketoconazole by is a Otc medication manufactured, distributed, or labeled by TAGRID LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ketoconazole 1%

PURPOSE

Anti Dandruff

INDICATIONS & USAGE

• Targets Stubborn Dandruff, Seborrheic Dermatitis, and itching
• ​Prevention, Treatment, and control of fungus that can cause dandruff

WARNINGS

For external use only

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

do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

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

ask a doctor before use

If swallowed, get medical help or contact a Posion Control Center immediately

DOSAGE & ADMINISTRATION

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 old Ask a doctor

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

store at 20°C to 25°C (68°F-77°F)
see top panel for lot number and expiration date

QUESTIONS

Support@tagridllc.com

INACTIVE INGREDIENT

Citric Acid, Herba Violae, Euphorbia Hirta, Murraya Paniculata ,Mentha Canadensis, Sophora Flavescens, Dittany Bark, Glabrous Greenbrier Rhizome, Mosla Cavaleriei Levl ,Stellera Chamaejasme, Huang Bai, Sessile Stemona Root, Gleditsia Sinensis, Common Cnidium Fruit, Fructus Kochiae, Tea Tree Oil, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

1% KETOCONAZOLE 
ketoconazole shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85384-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
STEMONA SESSILIFOLIA ROOT (UNII: EKG8030U4N)
GLEDITSIA SINENSIS THORN (UNII: 26LKE578NY)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
MURRAYA PANICULATA ROOT BARK (UNII: 20IWV81WFV)
DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)
STELLERA CHAMAEJASME WHOLE (UNII: 80N0P0DD9J)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
CITRIC ACID (UNII: 2968PHW8QP)
SMILAX GLABRA TUBER (UNII: PES3YXA3LR)
WATER (UNII: 059QF0KO0R)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
MENTHA CANADENSIS TOP OIL (UNII: N2285224W8)
EUPHORBIA HIRTA (UNII: L13YF113GN)
MOSLA CAVALERIEI WHOLE (UNII: 05O8B64OS2)
VIOLA YEZOENSIS WHOLE (UNII: 9OI75F9NAC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85384-0001-1	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/31/2025

Labeler - TAGRID LLC (118778969)