DANDRX 1% KETOCONAZOLE ANTI-DANDRUFF- dandrx 1% ketoconazole anti-dandruff shampoo liquid

dandRX 1% Ketoconazole Anti-Dandruff by

Drug Labeling and Warnings

dandRX 1% Ketoconazole Anti-Dandruff by is a Otc medication manufactured, distributed, or labeled by dandRX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

KETOCONAZOLE 1%

Purpose

Anti-dandruff

Use

Use: for the control of the symptoms of dandruff and or seborrheic dermatitis.

Warnings

for external use only.

Do not use

Do not use on open skin wounds

WHEN USING

When using this product avoid contact witheyes,if contact occurs. rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Directions: for best results, use every other day or as directed by a doctor.

■ Wet hair thoroughly
■ Massage a liberal amount into your scalp.
■ Leave lather on scalp for several minutes
■ Rinse and repeat

Other information

Other information: store at room
temperature between 68-78°F(20-25°C).
Do not expose to excessive heat.

Inactive ingredients

Aqua, Aloe Vera Leaf, Sodium Cocoyl Isethion-ate, Sodium LauroyI Methyl Isethionate, Co-
camidopropyl Hydroxysultaine, Oatmeal, Pan-thenol, Chamomile, Green Tea Leaf, Calendula
Officinalis Flower, Glycerin, Squalane, Cocos Nucifera (Coconut) Oil, Melaleuca Alternifolia
(Tea Tree) Leaf Oil, Azadirachta Indica Flower, Leuconostoc/Radish Root Ferment Filtrate, So-
dium Benzoate, Citric Acid

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

DANDRX 1% KETOCONAZOLE ANTI-DANDRUFF 
dandrx 1% ketoconazole anti-dandruff shampoo liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85521-001
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
GLYCERIN (UNII: PDC6A3C0OX)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
AQUA (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
OATMEAL (UNII: 8PI54V663Y)
PANTHENOL (UNII: WV9CM0O67Z)
CHAMOMILE (UNII: FGL3685T2X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SODIUM BENZOATE (UNII: OJ245FE5EU)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
SQUALANE (UNII: GW89575KF9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85521-001-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/09/2025

Labeler - dandRX LLC (137339129)

Establishment
Name	Address	ID/FEI	Business Operations
dandRX LLC		137339129	manufacture(85521-001)