84558-010

84558-010
SPL v1
SPL
SPL Set ID 3979fb80-8091-c79e-e063-6394a90ae618
Route
TOPICAL
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 g)
Inactive Ingredients
Lecithin, Sunflower Coco-glucoside Aqua Carbomer Piroctone Olamine C12-15 Pareth-3 Sodium Lauroyl Sarcosinate Cocamidopropyl Betaine Lauramidopropyl Betaine Menthol O-cymen-5-ol Peg-120 Methyl Glucose Dioleate Melaleuca Alternifolia (tea Tree) Leaf Oil Polyquaternium-10 (125 Mpa.s At 2%) Hydroxyphenyl Propamidobenzoic Acid Phenoxyethanol Panthenol Maltooligosyl Glucoside Glycerin Biotin Platycladus Orientalis Leaf Rosmarinus Officinalis (rosemary) Leaf Powder Fragrance 13576 Aloe Barbadensis Leaf Panax Ginseng Root Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-09

Description

Salicylic acid 3%

Purpose

Anti-dandruff


Medication Information

Purpose

Anti-dandruff



Description

Salicylic acid 3%

Use

Helps prevent recurrence of the scalp: irritation,

itching, redness, flaking and scaling associated with

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

condition worsens or does not improve after regular use of this product as directed

Section 50567-7

1. avoid contact with eyes

2. if contact occurs, rinse eyes thoroughly with water







Warnings

For external use only

Consult a doctor before use if you

■ are allergic to ingredients in this product

When using this product

■ avoid contact with eyes

■ if contact occurs, rinse eyes thoroughly with water

Stop use and consult a doctor if

■ condition worsens or does not improve after regular use of this product as directed

Directions

1. For best results, use at least twice a week or as directed by a doctor

2. Wet hair thoroughly, massage shampoo into scalp, leave on for 3-5 minutes to allow maximum

absorption. Then rinse thoroughly and repeat as needed



Do Not Use

Do not use if allergic to the ingredients in this product

Other Information

No Data

Active Ingredient(s)

Salicylic acid 3%



Inactive Ingredients

Aqua, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Lauramidopropyl Betaine,Lecithin, Coco-Glucoside, Peg-120

MethyI Glucose Dioleate, Aloe Barbadensis Leaf Extract, HydroxyphenyI Propamidobenzoic Acid, Phenoxyethanol,

Menthol, Polyquaternium 10, Panthenol, Maltooligosyl Glucoside, Lindera Strychnifolia Extract, Carbomer, Piroctone

Olamine, Glycerin, Biotin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thuja Orientalis Leaf Extract, Panax Ginseng Root Extract,

Angelica Sinensis Extract, Zingiber Officinale (Ginger) Root Extract, Polygonum Multiflorum Extract, Rosmarinus

Officinalis (Rosemary) Leaf Extract, Fragrance, O-Cymen-5-Ol, Hydroxypropyltrimonium Hyaluronate, C12-15 Pareth-3,

Hydroxypropyltrimonium Hydrolyzed Collagen



Package Label Principal Display Panel


Structured Label Content

Use

Helps prevent recurrence of the scalp: irritation,

itching, redness, flaking and scaling associated with

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)

condition worsens or does not improve after regular use of this product as directed

Section 50567-7 (50567-7)

1. avoid contact with eyes

2. if contact occurs, rinse eyes thoroughly with water







Purpose

Anti-dandruff



Warnings

For external use only

Consult a doctor before use if you

■ are allergic to ingredients in this product

When using this product

■ avoid contact with eyes

■ if contact occurs, rinse eyes thoroughly with water

Stop use and consult a doctor if

■ condition worsens or does not improve after regular use of this product as directed

Directions

1. For best results, use at least twice a week or as directed by a doctor

2. Wet hair thoroughly, massage shampoo into scalp, leave on for 3-5 minutes to allow maximum

absorption. Then rinse thoroughly and repeat as needed



Do Not Use (Do not use)

Do not use if allergic to the ingredients in this product

Other Information (Other information)

No Data

Active Ingredient(s)

Salicylic acid 3%



Inactive Ingredients (Inactive ingredients)

Aqua, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Lauramidopropyl Betaine,Lecithin, Coco-Glucoside, Peg-120

MethyI Glucose Dioleate, Aloe Barbadensis Leaf Extract, HydroxyphenyI Propamidobenzoic Acid, Phenoxyethanol,

Menthol, Polyquaternium 10, Panthenol, Maltooligosyl Glucoside, Lindera Strychnifolia Extract, Carbomer, Piroctone

Olamine, Glycerin, Biotin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thuja Orientalis Leaf Extract, Panax Ginseng Root Extract,

Angelica Sinensis Extract, Zingiber Officinale (Ginger) Root Extract, Polygonum Multiflorum Extract, Rosmarinus

Officinalis (Rosemary) Leaf Extract, Fragrance, O-Cymen-5-Ol, Hydroxypropyltrimonium Hyaluronate, C12-15 Pareth-3,

Hydroxypropyltrimonium Hydrolyzed Collagen



Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)