Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID a27273f7-d84f-4390-947b-3b9b5e0bca6e
Route
TOPICAL
Published
Effective Date 2011-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (18 mg)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Glyceryl Laurate Green Tea Leaf Alcohol Aloe Vera Leaf Polysorbate 20 Glycerin Panthenol Vitamin A Palmitate Cholecalciferol Lavender Oil Orange Oil Corn Oil Edetate Sodium Dmdm Hydantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-01

Description

Active Ingredients: Salicylic Acid 1.8%


Medication Information

Warnings and Precautions

Warnings:

  • For external use only.

Indications and Usage

Uses:

For relief of itching and scalp flaking associated with dandruff, seborrheic dermatitis and psoriasis.

Dosage and Administration
Directions

For best control of dandruff, use every time you shampoo. Wet hair, massage shampoo onto scalp, wait for at least 2 minutes, rinse, repeat if necessary.

For best results use at least twice a week or as directed by a doctor
Description

Active Ingredients: Salicylic Acid 1.8%

Section 50565-1
Keep out of reach of small children. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3
If swallowed, get medical help or contact a Poison Control Center immediately. If condition worsens or does not improve after regular use of this product as directed, consult a doctor.







Section 51727-6


Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Stach Hydroxypropyltrimonium Chloride, Glycerol Laurate, Green Tea Leaf Extract, SD Alcohol 40 (Alcohol Denatured), Aloe barbadensis Leaf Juice, Polysorbate 20, Glycerin, Panthenol, Retinyl Palmitate, Cholecalciferol, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Zea Mays (Corn) Oil, Tetrasodium EDTA, DMDM Hydantoin.











Section 51945-4
Section 55105-1

Purpose: 

Help Control of flaking and itching associated with dandruff and scalp psoriasis

Section 55106-9

Active Ingredients:

Salicylic Acid 1.8%


Structured Label Content

Indications and Usage (34067-9)

Uses:

For relief of itching and scalp flaking associated with dandruff, seborrheic dermatitis and psoriasis.

Dosage and Administration (34068-7)
Directions

For best control of dandruff, use every time you shampoo. Wet hair, massage shampoo onto scalp, wait for at least 2 minutes, rinse, repeat if necessary.

For best results use at least twice a week or as directed by a doctor
Warnings and Precautions (34071-1)

Warnings:

  • For external use only.

Section 50565-1 (50565-1)
Keep out of reach of small children. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3 (50569-3)
If swallowed, get medical help or contact a Poison Control Center immediately. If condition worsens or does not improve after regular use of this product as directed, consult a doctor.







Section 51727-6 (51727-6)


Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Stach Hydroxypropyltrimonium Chloride, Glycerol Laurate, Green Tea Leaf Extract, SD Alcohol 40 (Alcohol Denatured), Aloe barbadensis Leaf Juice, Polysorbate 20, Glycerin, Panthenol, Retinyl Palmitate, Cholecalciferol, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Zea Mays (Corn) Oil, Tetrasodium EDTA, DMDM Hydantoin.











Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Purpose: 

Help Control of flaking and itching associated with dandruff and scalp psoriasis

Section 55106-9 (55106-9)

Active Ingredients:

Salicylic Acid 1.8%


Advanced Ingredient Data


Raw Label Data

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