POAGCI KETOCONAZOLE VCP-KAD001- ketoconazole liquid 
Vince (Guangzhou) Cosmetics Co., Ltd.

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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

84745-002-01 Label

POAGCI KETOCONAZOLE VCP-KAD001 
ketoconazole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84745-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84745-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/11/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03210/11/2024
Labeler - Vince (Guangzhou) Cosmetics Co., Ltd. (978423301)
Establishment
NameAddressID/FEIBusiness Operations
Vince (Guangzhou) Cosmetics Co., Ltd.978423301manufacture(84745-002)

Revised: 10/2024
Document Id: 2435001f-82a9-a781-e063-6394a90a9628
Set id: 2435001f-82a8-a781-e063-6394a90a9628
Version: 1
Effective Time: 20241011
 
Vince (Guangzhou) Cosmetics Co., Ltd.