SPL v1
SPL
SPL Set ID 286c5fbb-74c0-7de3-e063-6394a90a0973
Route
CUTANEOUS
Published
Effective Date 2024-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ketoconazole (1 g)
Inactive Ingredients
Dodecylbenzenesulfonic Acid Aqua Sodium Laureth Sulfate Cocamidopropyl Betaine Cocamide Dea Dimethicone Sodium Chloride Glycol Distearate Carbomer Azelaic Acid Laurtrimonium Chloride Guar Hydroxypropyltrimonium Chloride Methylisothiazolinone Citric Acid C12-15 Pareth-3 Coco/oleamidopropyl Betaine Triethanolamine Fd&c Blue No. 1 Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-04

Description

Ketoconazole 1%

Purpose

Anti-dandruff shampoo


Medication Information

Purpose

Anti-dandruff shampoo



Description

Ketoconazole 1%

Use

controls flaking, scaling and itching from dandruff



Section 50565-1

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away,



Section 50566-9

rash appears

condition worsens or does not improve in 2-4 weeks



Section 50567-7

avoid contact with eyes

in case of such contact, rinse well with water



Warnings

For external use only



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





Do Not Use

on scalp that is broken or inflamed

if there is a known sensitivity to any of the ingredients



Other Information

①store at 20°C to 25°C (68*F-77°F)

②see bottom panel for expiration date



Active Ingredient(s)

Ketoconazole 1%



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


Structured Label Content

Use

controls flaking, scaling and itching from dandruff



Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away,



Section 50566-9 (50566-9)

rash appears

condition worsens or does not improve in 2-4 weeks



Section 50567-7 (50567-7)

avoid contact with eyes

in case of such contact, rinse well with water



Purpose

Anti-dandruff shampoo



Warnings

For external use only



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





Do Not Use (Do not use)

on scalp that is broken or inflamed

if there is a known sensitivity to any of the ingredients



Other Information (Other information)

①store at 20°C to 25°C (68*F-77°F)

②see bottom panel for expiration date



Active Ingredient(s)

Ketoconazole 1%



Inactive Ingredients (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 (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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