SPL v1
SPL
SPL Set ID 3efbb5a6-0a45-47f1-a769-04455256918d
Route
TOPICAL
Published
Effective Date 2014-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2.0 g)
Inactive Ingredients
Aloe Vera Leaf Water Sodium Coco-sulfate Coco Glucoside Glyceryl Oleate Chamomile Melaleuca Alternifolia Leaf Rosmarinus Officinalis Flower Styrax Benzoin Resin Canarium Luzonicum Whole Cedrus Atlantica Bark Oil Orange Oil Lemon Oil Copaifera Officinalis Resin Coriander Oil Geranium Maculatum Whole Lavender Oil Mentha Arvensis Leaf Oil Mentha Piperita Pogostemon Cablin Whole Rosemary Oil .alpha.-bisabolol, (+)- Disodium Cocoyl Glutamate Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Inulin Menthol Potassium Hydroxide Sodium Cocoyl Glutamate Sodium Sulfate .alpha.-tocopherol Acetate Alcohol Benzyl Alcohol Potassium Sorbate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-01-29
Description

For external use only. Avoid contact with eyes. Rinse eyes throughly with water in case contact ossurs. Discontinue to use and contact your physician if irritation develops.

Medication Information

Warnings and Precautions



For external use only. Avoid contact with eyes. Rinse eyes throughly with water in case contact ossurs. Discontinue to use and contact your physician if irritation develops.

Indications and Usage

For relief of flaking, scaling and itching associated with dandruff. Helps prevent Seborrheic Dermatitis

Dosage and Administration

For the best results use at least three times each week. Wet hair, lather, massage onto scalp. Rinse and repeat if desired.

Description

For external use only. Avoid contact with eyes. Rinse eyes throughly with water in case contact ossurs. Discontinue to use and contact your physician if irritation develops.

Section 50565-1

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

Section 51727-6

Aloe Barbadensis Leaf Juice (1),Aqua (Water), Sodium Coco-Sulfate, Cococ-Glucoside, Glyceryl Oleate, Chamomilla Recuitita (Matricaria) Flower Extract (1), Malaleuca Alternifolia (Tea Tree) Leaf Oil (1), Rosmarinus Officinalis (Rosemary) extract, Styrax Benzoin Resin Extract (1), Canarium Luzonicum Gum Nonvolatiles, Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange Peel Oil, Citrus Limon (Lemon) Peel Oil,

Section 51945-4

Section 55105-1

Controls symptoms of dandruff, seboric dermatitis and psoriasis

Drug Facts

Salicylic Acid    2.0%

Structured Label Content

Indications and Usage (34067-9)

For relief of flaking, scaling and itching associated with dandruff. Helps prevent Seborrheic Dermatitis

Dosage and Administration (34068-7)

For the best results use at least three times each week. Wet hair, lather, massage onto scalp. Rinse and repeat if desired.

Warnings and Precautions (34071-1)



For external use only. Avoid contact with eyes. Rinse eyes throughly with water in case contact ossurs. Discontinue to use and contact your physician if irritation develops.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Juice (1),Aqua (Water), Sodium Coco-Sulfate, Cococ-Glucoside, Glyceryl Oleate, Chamomilla Recuitita (Matricaria) Flower Extract (1), Malaleuca Alternifolia (Tea Tree) Leaf Oil (1), Rosmarinus Officinalis (Rosemary) extract, Styrax Benzoin Resin Extract (1), Canarium Luzonicum Gum Nonvolatiles, Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange Peel Oil, Citrus Limon (Lemon) Peel Oil,

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Controls symptoms of dandruff, seboric dermatitis and psoriasis

Drug Facts

Salicylic Acid    2.0%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:44.893079 · Updated: 2026-03-14T22:53:40.468762