84558-012

84558-012
SPL v1
SPL
SPL Set ID 3b102d15-f2ce-5727-e063-6294a90a23a9
Route
TOPICAL
Published
Effective Date 2025-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Piroctone (0.08 g) Salicylic Acid (2 g)
Inactive Ingredients
Aloe Barbadensis Leaf Juice Guaraprolose (1300 Mpa.s At 1%) Cinchona Pubescens Bark Disodium Phosphate Saccharide Isomerate Aminobutyric Acid 1,2-hexanediol Sodium Phosphate Glycol Stearate Phellodendron Amurense Bark Phenoxyethanol Dmdm Hydantoin Butylene Glycol Citric Acid Hydroxyethylcellulose Rosa Laevigata Fruit Ethylhexylglycerin Menthyl Lactate Sophora Flavescens Root Menthol Dextrin, Corn Polysorbate 60 Hydroxyacetophenone Maize Invert Sugar Aqua Sodium Laureth Sulfate Sodium Chloride Glycol Distearate Cocamidopropyl Betaine Sorbitol Glycerin Polyquaternium-10 (1000 Mpa.s At 2%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-30

Description

SALICYLIC ACID 2% PIROCTONE OLAMINE 0.08%

Purpose

Scalp treatment fights itching and flaking Anti-dandruff


Medication Information

Purpose

Scalp treatment

fights itching and flaking

Anti-dandruff

Description

SALICYLIC ACID 2% PIROCTONE OLAMINE 0.08%

Use

Relieves and helps prevent recurrence of scalp: itching,

flaking, scaling, redness, and iritation associated with

psoriasis and seborrheic dermatitis.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

Section 50566-9

Stop use and ask a doctor if condition worsens or does not improve.

Section 50567-7

When using this product:

Avoid contact with eyes.

If contact occurs, rnse thoroughly with water.

Warnings

For external use only

Ask a doctor before use if you have allergic reactions to this product

Directions

1. Apply shampoo and massage into scalp.

2. Leave in hair for 3- 5 minutes to allow maximum penetration.

3. Rinse and repeat as needed.

4. Use daily for best results.

5. Do not use on children under 2 years unless directed by a doctor.

Do Not Use

Do not use on children under 2 years unless directed by a doctor.

Other Information

Store at room temperature and out of direct sunlight

Active Ingredient(s)

SALICYLIC ACID 2%

PIROCTONE OLAMINE 0.08%

Inactive Ingredients

AQUA, SODIUM LAURETH SULFATE, SODIUM CHLORIDE,

GLYCOL DISTEARATE, PAL .M KERNEL AMIDE DEA, SODIUM

L AUROYL COLLAGEN AMINO ACIDS, COCAMIDOPROPYL

BETAINE, FRAGRANCE, SORBITOL, GLYCOL STEARATE, DMDM

HYDANTOIN, SACCHARIDE HYDROLYSATE, ALOE

BARBADENSIS L EAF JUICE, HYDROXYETHYLCELLULOSE,

GLYCERIN, BUTYL ENE GLYCOL, HYDROXYPROPYL GUAR,

POLYQUATERNIUM-10, CITRIC ACID, CINCHONA PUBESCENS

BARK EXTRACT, MENTHYL LACTATE, SOPHORA FLAVESCENS

ROOT EXTRACT,PHEL LODENDRON AMURENSE BARK

EXTRACT, ATRACTYLODES CHINENSIS RHIZOME EXTRACT,

DEXTRIN, PHENOXYETHANOL, SACCHARIDE ISOMERATE,

AMINOBUTYRIC ACID, 1,2-HEXANEDIOL,

ETHYL HEXYL GLYCERIN, POLYSORBATE 60, DISODIUM

PHOSPHATE, MENTHOLUM, HYDROXYACETOPHENONE,

VIOL A YEDOENSIS EXTRACT, SODIUM PHOSPHATE, ROSA

L AEVIGATA FRUIT EXTRACT, SESAME AMINO ACIDS

Package Label Principal Display Panel


Structured Label Content

Use

Relieves and helps prevent recurrence of scalp: itching,

flaking, scaling, redness, and iritation associated with

psoriasis and seborrheic dermatitis.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or does not improve.

Section 50567-7 (50567-7)

When using this product:

Avoid contact with eyes.

If contact occurs, rnse thoroughly with water.

Purpose

Scalp treatment

fights itching and flaking

Anti-dandruff

Warnings

For external use only

Ask a doctor before use if you have allergic reactions to this product

Directions

1. Apply shampoo and massage into scalp.

2. Leave in hair for 3- 5 minutes to allow maximum penetration.

3. Rinse and repeat as needed.

4. Use daily for best results.

5. Do not use on children under 2 years unless directed by a doctor.

Do Not Use (Do not use)

Do not use on children under 2 years unless directed by a doctor.

Other Information (Other information)

Store at room temperature and out of direct sunlight

Active Ingredient(s)

SALICYLIC ACID 2%

PIROCTONE OLAMINE 0.08%

Inactive Ingredients (Inactive ingredients)

AQUA, SODIUM LAURETH SULFATE, SODIUM CHLORIDE,

GLYCOL DISTEARATE, PAL .M KERNEL AMIDE DEA, SODIUM

L AUROYL COLLAGEN AMINO ACIDS, COCAMIDOPROPYL

BETAINE, FRAGRANCE, SORBITOL, GLYCOL STEARATE, DMDM

HYDANTOIN, SACCHARIDE HYDROLYSATE, ALOE

BARBADENSIS L EAF JUICE, HYDROXYETHYLCELLULOSE,

GLYCERIN, BUTYL ENE GLYCOL, HYDROXYPROPYL GUAR,

POLYQUATERNIUM-10, CITRIC ACID, CINCHONA PUBESCENS

BARK EXTRACT, MENTHYL LACTATE, SOPHORA FLAVESCENS

ROOT EXTRACT,PHEL LODENDRON AMURENSE BARK

EXTRACT, ATRACTYLODES CHINENSIS RHIZOME EXTRACT,

DEXTRIN, PHENOXYETHANOL, SACCHARIDE ISOMERATE,

AMINOBUTYRIC ACID, 1,2-HEXANEDIOL,

ETHYL HEXYL GLYCERIN, POLYSORBATE 60, DISODIUM

PHOSPHATE, MENTHOLUM, HYDROXYACETOPHENONE,

VIOL A YEDOENSIS EXTRACT, SODIUM PHOSPHATE, ROSA

L AEVIGATA FRUIT EXTRACT, SESAME AMINO ACIDS

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


Advanced Ingredient Data


Raw Label Data

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