POAGCI KETOCONAZOLE VCP-KAD001- ketoconazole liquid

POAGCI Ketoconazole VCP-KAD001 by

Drug Labeling and Warnings

POAGCI Ketoconazole VCP-KAD001 by is a Otc medication manufactured, distributed, or labeled by Vince (Guangzhou) Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ketoconazole 1% w/w

Purpose

Anti-dandruff shampoo

Uses

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 produc

When using this product

avoid contact with eyes
if product gets into eyes, rinse thoroughly with water

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 dandruf

children under 12 years

ask a doctor

Other information

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

Inactive ingredients

Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Sodium Lauryl Sulfate, Dimethicone, Dimethiconol, Disodium Laureth Sulfosuccinate, Zinc Pyrithione, Phenoxyethanol, Fragrance, Sodium Cocoyl Alaninate, Caprylyl/Capryl Glucoside, Guar Hydroxypropyltrimonium Chloride, Salicylic Acid, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyquaternium-67, Glycerin, Sodium Hydroxide, Cetrimonium Chloride, Benzoic Acid, Acrylamidopropyltrimonium Chloride/Acrylamide Copolymer, Piroctone Olamine, Laureth-23, Tea-Dodecylbenzenesulfonate, Sodium Polynaphthalenesulfonate, DMDM Hydantoin, Sodium Benzoate, Cellulose Gum, Ethylhexylglycerin, CI 16255

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POAGCI KETOCONAZOLE VCP-KAD001 
ketoconazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84745-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84745-002-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	10/11/2024

Labeler - Vince (Guangzhou) Cosmetics Co., Ltd. (978423301)

Establishment
Name	Address	ID/FEI	Business Operations
Vince (Guangzhou) Cosmetics Co., Ltd.		978423301	manufacture(84745-002)