SPL v1
SPL
SPL Set ID e5b6877a-1417-4e88-a62d-76716ba2a92a
Route
TOPICAL
Published
Effective Date 2014-02-04
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 Glyceryl Stearate Se Caprylic/capric Mono/diglycerides Stearic Acid Cetyl Alcohol Sunflower Oil Diheptyl Succinate Stearyl Alcohol Olive Oil Jojoba Oil Shea Butter Chamomile Eucalyptus Globulus Leaf Lavandula Angustifolia Flower Melaleuca Alternifolia Leaf Rosmarinus Officinalis Flower Styrax Benzoin Resin Cedrus Atlantica Bark Oil Orange Oil Lemon Oil Copaifera Officinalis Resin Coriander Oil Geranium Maculatum Whole Lavender Oil Mentha Piperita Pogostemon Cablin Whole Rosemary Oil .alpha.-bisabolol, (+)- Disodium Cocoyl Glutamate Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Menthol .alpha.-tocopherol Acetate Xanthan Gum Alcohol Benzyl Alcohol Potassium Sorbate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-01-17

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. Apply to clean, wet hair. Rinse throughly.

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), Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Stearic Acid,Cetyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Helianthus Annuus (Sunflower Seed Oi (1), Diheptyl Succinate, Stearyl Alcohol, Olea Europaea (Olive) Fruit Oil (1l, Simmondsia Chinensis (Jojoba) Seed Oil (1), Butyrospermum Parkii (Shea) Butter (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Eucalyptus Globulus Leaf Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract (1), Rosmarinus Officinalis (Rosemmary) Leaf Extract (1), Styrax Benzoin Resin Extract, Malaleuca Alternifolia (Tea Tree) Leaf Oil (1), Rosmarinus Officinalis (Rosemary) Leaf Oil , Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange Peel Oil, Citrus Limon (Lemon) Peel Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Coriandrum Sativum (Coriander) Fruit Oil, Geranium Maculatum Oil, Lavandula Angustifolia  (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Pogostemon Cablin Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Wheat Protein, Menthol, Tocopheryl Acetate, Xanthan Gum, Alcohol, Benzyl Alcohol, Sodium Benzoate, Potassium Sorbate

(1) Certified Organic Ingredients

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. Apply to clean, wet hair. Rinse throughly.

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), Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Stearic Acid,Cetyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Helianthus Annuus (Sunflower Seed Oi (1), Diheptyl Succinate, Stearyl Alcohol, Olea Europaea (Olive) Fruit Oil (1l, Simmondsia Chinensis (Jojoba) Seed Oil (1), Butyrospermum Parkii (Shea) Butter (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Eucalyptus Globulus Leaf Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract (1), Rosmarinus Officinalis (Rosemmary) Leaf Extract (1), Styrax Benzoin Resin Extract, Malaleuca Alternifolia (Tea Tree) Leaf Oil (1), Rosmarinus Officinalis (Rosemary) Leaf Oil , Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange Peel Oil, Citrus Limon (Lemon) Peel Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Coriandrum Sativum (Coriander) Fruit Oil, Geranium Maculatum Oil, Lavandula Angustifolia  (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Pogostemon Cablin Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Wheat Protein, Menthol, Tocopheryl Acetate, Xanthan Gum, Alcohol, Benzyl Alcohol, Sodium Benzoate, Potassium Sorbate

(1) Certified Organic Ingredients

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

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