Initial Drug Listing - Scalp Treatment Shampoo

ketoconazole 1%

Anti Dandruff

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

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

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

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

Support@tagridllc.com

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

scalp shampoo

1% KETOCONAZOLE
ketoconazole shampoo

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - TAGRID LLC (118778969)