SPL v3
SPL
SPL Set ID 0786fca9-ee00-2f59-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2014-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Glycyrrhiza Glabra Bergamot Oil Salix Alba Bark Water Glycerin Aloe Vera Leaf Orange Oil Alcohol Hamamelis Virginiana Top Water Hydroxyethyl Cellulose (100 Mpa.s At 2%) Filipendula Ulmaria Flower Lens Culinaris Fruit Arnica Montana Flower Green Tea Leaf Calendula Officinalis Flower Peppermint Oil Chamomile Flower Oil Lavandula Angustifolia Flowering Top

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-10-01

Description

Active Ingredient Salicylic Acid 2.0%


Medication Information

Warnings and Precautions

For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.

Indications and Usage

For the treatment of acne.

Dosage and Administration

Cleanse face and apply directly to blemishes morning, evening and more frequently if needed.

Description

Active Ingredient Salicylic Acid 2.0%

Section 50565-1

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

Section 51727-6

Water, ,Glycerin, Alcohol, Aloe Barbadensis Leaf Juice(1), Hamamelis Verginiana (Witch Hazel) Water, Hydroxyethylcellulose, Spiraea Ulmaria Extract, Lens Esculenta (Lentil) Fruit Extract, Arnica Montana (Flower) Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1), Lavandula Angustifolia (Lavender) Extract (1), Glycyrrhiza Glabra (Licorice) Rhizome/Root, Salix Alba (Willow) Bark Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Aurantium Bergamia (Bergamot) Oil (2), Mentha Piperita (Peppermint) Oil (2)

(1) Certified Organicf Ingredient; (2) Natural Fragrance

Section 51945-4

Section 55105-1

Acne Treatment

Section 55106-9

Active Ingredient

Salicylic Acid 2.0%


Structured Label Content

Indications and Usage (34067-9)

For the treatment of acne.

Dosage and Administration (34068-7)

Cleanse face and apply directly to blemishes morning, evening and more frequently if needed.

Warnings and Precautions (34071-1)

For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water, ,Glycerin, Alcohol, Aloe Barbadensis Leaf Juice(1), Hamamelis Verginiana (Witch Hazel) Water, Hydroxyethylcellulose, Spiraea Ulmaria Extract, Lens Esculenta (Lentil) Fruit Extract, Arnica Montana (Flower) Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1), Lavandula Angustifolia (Lavender) Extract (1), Glycyrrhiza Glabra (Licorice) Rhizome/Root, Salix Alba (Willow) Bark Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Aurantium Bergamia (Bergamot) Oil (2), Mentha Piperita (Peppermint) Oil (2)

(1) Certified Organicf Ingredient; (2) Natural Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient

Salicylic Acid 2.0%


Advanced Ingredient Data


Raw Label Data

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