ANTI-FUNGAL- anti-fungal shampoo shampoo

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Ketoconazole 1%

PURPOSE

Anti-Fungal 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 product

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

KEEP OUT OF REACH OF CHILDREN

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.

Directions

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

- ask a doctor

Other information

- store at 20℃ to 25℃(68°F-77°F)

- see top panel for lot number and expiration date

Inactive ingredients

blue l, citric acid, cocamide MEA. mentha Piperita Oil.glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7.sodium benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide, tetrasodium EDTA, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI-FUNGAL 
anti-fungal shampoo shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87255-008
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)
COCAMIDE MEA (UNII: C80684146D)
DISPERSE BLUE 1 (UNII: 2429NAZ8WH)
POLYQUATERNIUM-7 (UNII: 0L414VCS5Y)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID (UNII: 2968PHW8QP)
TETRASODIUM EDTA (UNII: MP1J8420LU)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM COCOYL SARCOSINATE (UNII: 1R9DUY89CZ)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87255-008-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	01/12/2026

Labeler - Shenzhen Mengyue Technology Co., Ltd. (511200055)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Mengyue Technology Co., Ltd.		511200055	manufacture(87255-008)