85521-001

85521-001
SPL v1
SPL
SPL Set ID 324fb7bb-4b8e-e6e6-e063-6394a90adae1
Route
TOPICAL
Published
Effective Date 2025-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ketoconazole (1 g)
Inactive Ingredients
Glycerin Leuconostoc/radish Root Ferment Filtrate Aqua Sodium Cocoyl Isethionate Sodium Lauroyl Methyl Isethionate Cocamidopropyl Hydroxysultaine Oatmeal Panthenol Chamomile Green Tea Leaf Calendula Officinalis Flower Sodium Benzoate Cocos Nucifera (coconut) Oil Melaleuca Alternifolia (tea Tree) Leaf Oil Azadirachta Indica Flower Squalane Aloe Vera Leaf Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-09

Description

KETOCONAZOLE 1%

Purpose

Anti-dandruff


Medication Information

Purpose

Anti-dandruff



Description

KETOCONAZOLE 1%

Use

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

Section 50565-1

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



Section 50566-9

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



Section 50567-7

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



Warnings

for external use only.



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

Do Not Use

Do not use on open skin wounds

Other Information

Other information: store at room

temperature between 68-78°F(20-25°C).

Do not expose to excessive heat.



Active Ingredient(s)

KETOCONAZOLE 1%

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


Structured Label Content

Use

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

Section 50565-1 (50565-1)

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



Section 50566-9 (50566-9)

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



Section 50567-7 (50567-7)

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



Purpose

Anti-dandruff



Warnings

for external use only.



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

Do Not Use (Do not use)

Do not use on open skin wounds

Other Information (Other information)

Other information: store at room

temperature between 68-78°F(20-25°C).

Do not expose to excessive heat.



Active Ingredient(s)

KETOCONAZOLE 1%

Inactive Ingredients (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 (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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