83887-004

83887-004
SPL v1
SPL
SPL Set ID 2d38d7f4-6c99-182d-e063-6294a90a7b33
Route
TOPICAL
Published
Effective Date 2025-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ketoconazole (0.5 g)
Inactive Ingredients
Glycerin Propylene Glycol Peppermint Serine Sodium Cocoyl Isethionate Aloe Vera Leaf Coconut Oil Citric Acid Tea Tree Oil Witch Hazel Artemisia Argyi Leaf Licorice Arginine Aqua Rosemary Purslane Sodium Chloride Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-03

Description

ketoconazole 0.5%

Purpose

dandruff


Medication Information

Purpose

dandruff

Description

ketoconazole 0.5%

Use

controls flaking, scaling and itching associated with dandruff.

Stop Use

No improvement after 4 weeks of normal usage.

Warnings

For external use only.

Questions

[email protected]

www.pureskinsupport.com

Ask Doctor

irritation or rash occurs.

condition worsens or does not improve in 2-4 weeks.

Directions

Wet hair thoroughly.

Apply shampoo, gently lather and massage for 2 minutes, Rinse thoroughly.

Use 2-3 times per week for up to 8 weeks or as directed by a doctor

Do Not Use

on damaged or inflamed scalp.

if you are pregnant or breast feeding.

on children under 12 years old.

When Using

avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.

Keep out of the reach of young children.

Active Ingredient

ketoconazole 0.5%

Other Information

Store at 20°C to 25°C (68°F - 77°F)

Inactive Ingredients

Aqua

Glycerin

Sodium Cocoyl Isethionate

Propylene Glycol

Aloe Vera

Citric Acid

Rosemary

Tea Tree Oil

Witch Hazel

Chinese Mugwort Leaf

Licorice

Ethylhexylglycerin

Purslane

Sodium Chloride

Serine

Arginine

Coconut Oil

Peppermint

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children.

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


Structured Label Content

Use

controls flaking, scaling and itching associated with dandruff.

Purpose

dandruff

Stop Use

No improvement after 4 weeks of normal usage.

Warnings

For external use only.

Questions

[email protected]

www.pureskinsupport.com

Ask Doctor

irritation or rash occurs.

condition worsens or does not improve in 2-4 weeks.

Directions

Wet hair thoroughly.

Apply shampoo, gently lather and massage for 2 minutes, Rinse thoroughly.

Use 2-3 times per week for up to 8 weeks or as directed by a doctor

Do Not Use (Do not use)

on damaged or inflamed scalp.

if you are pregnant or breast feeding.

on children under 12 years old.

When Using

avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.

Keep out of the reach of young children.

Active Ingredient

ketoconazole 0.5%

Other Information (Other information)

Store at 20°C to 25°C (68°F - 77°F)

Inactive Ingredients (Inactive ingredients)

Aqua

Glycerin

Sodium Cocoyl Isethionate

Propylene Glycol

Aloe Vera

Citric Acid

Rosemary

Tea Tree Oil

Witch Hazel

Chinese Mugwort Leaf

Licorice

Ethylhexylglycerin

Purslane

Sodium Chloride

Serine

Arginine

Coconut Oil

Peppermint

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)