1% KETOCONAZOLE ANTI DANDRUFF- 1% ketoconazole anti dandruff shampoo shampoo

1% ketoconazole anti dandruff by

Drug Labeling and Warnings

1% ketoconazole anti dandruff by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ketoconazole 1%

Purpose

Anti-dandruff shampoo

Use

controls flaking, scaling and itching from dandruff

Warnings

For external use only

Do not use

on scalp that is broken or inflamed

if there is a known sensitivity to any of the ingredients

WHEN USING

avoid contact with eyes
in case of such contact, rinse well with water

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

Directions

adults and children 12 years and over：①wet hair thoroughly ②apply shampoo, generously lather, rinse thoroughly. Repeat
③use 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

Other information

①store at 20°C to 25°C (68*F-77°F)
②see bottom panel for expiration date

Inactive ingredients

Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide Dea, Dimethicone, Sodium Chloride, Glycol Distearate,
Amino BispropyI Dimethicone, Fragrance, Polyquaternium-10, Carbomer, Azelaic Acid, L aurtrimonium Chloride, Guar
Hydroxypropyltrimonium Chloride, Methylisothiazolinone, Citric Acid, Coco/Oleamidopropyl Betaine, Dodecylbenzene Sulfonic
Acid, C12-15 Pareth-3, Hydroxypropyltrimonium Hydrolyzed Collagen, Triethanolamine, Phenoxyethanol, AO1

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

1% KETOCONAZOLE ANTI DANDRUFF 
1% ketoconazole anti dandruff shampoo shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84558-005
Route of Administration	CUTANEOUS

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
DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)
AQUA (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDE DEA (UNII: 92005F972D)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
CARBOMER (UNII: 0A5MM307FC)
AZELAIC ACID (UNII: F2VW3D43YT)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID (UNII: 2968PHW8QP)
C12-15 PARETH-3 (UNII: 459EF9MP3Y)
COCO/OLEAMIDOPROPYL BETAINE (UNII: 5M84PX7JN2)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84558-005-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	12/04/2024

Labeler - GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd (545488483)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd		545488483	manufacture(84558-005)