85150-003

85150-003
SPL v1
SPL
SPL Set ID 2c62d04e-dcb6-a33e-e063-6394a90a2e8e
Route
TOPICAL
Published
Effective Date 2025-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hexamidine (0.1 g) Salicylic Acid (3 g)
Inactive Ingredients
Freesia Alba Flower Tea Tree Oil Dimethicone Glycol Distearate Coptis Chinensis Root Citric Acid Dihydrogenated Tallow Phthalic Acid Amide Piroctone Olamine Guar Hydroxypropyltrimonium Chloride Houttuynia Cordata Flowering Top Cetostearyl Alcohol Water Glycol Stearate C12-15 Alkyl Ethylhexanoate Menthol Edetate Disodium Sodium Lauroamphoacetate Sodium Laureth Sulfate Rheum Officinale Root Glycerin Fallopia Multiflora Root Asian Ginseng

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-24

Description

HEXAMIDINE DIISETHIONATE 0.1% W/W / SALICYLIC ACID 3% W/W

Purpose

Scalp treatment, fights itching and flaking.


Medication Information

Purpose

Scalp treatment,

fights itching and flaking.

Description

HEXAMIDINE DIISETHIONATE 0.1% W/W / SALICYLIC ACID 3% W/W

Use

Controls and relives symptoms of Dandruff, Psoriasis, Folliculitis and Seborrheic Dermatitis.

Stop Use

if condition worsens or does not improve after regular use as directed.

Warnings

■ For external use only.

■ Ask a doctore before use if you are allergic to ingredients in this products.

■ When using this product avoid contact with eyes. If contact occurs, flush eyes with copious amounts of cold tap water.

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

Ask Doctor

If pregnant or breast-feeding ask a health professional before use.

Directions

■ Apply shampoo and massage into the scalp.

■ Leave in hair for 3-5 minutes to allow maximum absorption.

■ Rinse thoroughly with water.

■ Use 2-4 times per week or as needed.

Do Not Use

If pregnant or breast-feeding ask a health professional before use.

This product is not recommended for individuals under 18 years of age.

When Using

When using this product avoid contact with eyes. If contact occurs, flush eyes with copious amounts of cold tap water.

Active Ingredient

HEXAMIDINE DIISETHIONATE 0.1% W/W /

SALICYLIC ACID 3% W/W

Other Information

■Read all information on package before use.

■Save the box. Contains important information.

■Store at controlled room temperature 20-25°C (68-77°F).

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cetearyl Alcohol, Dimethicone, Glycol Distearate, Glycol Stearate, Sodium Lauroamphoacetate, Di(Hydrogenated Tallow) Phthalic Acid Amide, C12-15 Alkyl Eth-3, Menthol, Piroctone Olamine, Glycerin, Guar Hydroxypropyltrimonium Chloride, Coptis Chinensis Extract, Rheum Officinale Extract, Polygonum Multiflorum Root Extract, Houttuynia Cordata Extract, Foeniculum Vulgaris Extract, Taraxacum Mongolicum Extract, Nymphea Alba Flower Extract, Panax Ginseng Root Extract, Tea Tree Essential Oil, Citric Acid, Disodium EDTA.

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 (1-800-222-1222) right away.


Structured Label Content

Use

Controls and relives symptoms of Dandruff, Psoriasis, Folliculitis and Seborrheic Dermatitis.

Purpose

Scalp treatment,

fights itching and flaking.

Stop Use

if condition worsens or does not improve after regular use as directed.

Warnings

■ For external use only.

■ Ask a doctore before use if you are allergic to ingredients in this products.

■ When using this product avoid contact with eyes. If contact occurs, flush eyes with copious amounts of cold tap water.

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

Ask Doctor

If pregnant or breast-feeding ask a health professional before use.

Directions

■ Apply shampoo and massage into the scalp.

■ Leave in hair for 3-5 minutes to allow maximum absorption.

■ Rinse thoroughly with water.

■ Use 2-4 times per week or as needed.

Do Not Use (Do not use)

If pregnant or breast-feeding ask a health professional before use.

This product is not recommended for individuals under 18 years of age.

When Using

When using this product avoid contact with eyes. If contact occurs, flush eyes with copious amounts of cold tap water.

Active Ingredient

HEXAMIDINE DIISETHIONATE 0.1% W/W /

SALICYLIC ACID 3% W/W

Other Information (Other information)

■Read all information on package before use.

■Save the box. Contains important information.

■Store at controlled room temperature 20-25°C (68-77°F).

Inactive Ingredients (Inactive ingredients)

Water, Sodium Laureth Sulfate, Cetearyl Alcohol, Dimethicone, Glycol Distearate, Glycol Stearate, Sodium Lauroamphoacetate, Di(Hydrogenated Tallow) Phthalic Acid Amide, C12-15 Alkyl Eth-3, Menthol, Piroctone Olamine, Glycerin, Guar Hydroxypropyltrimonium Chloride, Coptis Chinensis Extract, Rheum Officinale Extract, Polygonum Multiflorum Root Extract, Houttuynia Cordata Extract, Foeniculum Vulgaris Extract, Taraxacum Mongolicum Extract, Nymphea Alba Flower Extract, Panax Ginseng Root Extract, Tea Tree Essential Oil, Citric Acid, Disodium EDTA.

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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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